3500 A Flashcards
What Types of FDA Regulated Products Can You Report Through MedWatch?
- Prescription and over-the-counter meds.
- Biologics
- Medical devices
- Combination products
- Special nutritional products
- Cosmetics
- Food
When is a Malfunction considered to be reportable?
A malfunction is reportable when it is likely to cause or contribute to a death or serious injury if it were to recur.
What goes in Section A?
PT Information
What information goes in Section B?
Information about the Adverse Event and/or Product Problem.
What constitues a serious injury as defined in 21 CFR 803.3
A serious injury or illness, as defined by 21CFR 803.3, meets one of these criteria:
- Is life-threatening
- Results in permanent impairment of a body function or permanent damage to a body structure
- Necessitates medical or surgical intervention to preclude or correct any permanent damage or impairment of a body function or structure.
What’s the format that dates must be entered on the form?
DD-MMM-YYYY
- E.X.: 07 JUL 2023
What two functions does MedWatch provide?
- MedWatch provides a platform to report Adverse Events and Product Problems
- MedWatch also provides updated informaiton related to the medical product for providers and the public
In what instance does the Original Equipment Manufacturer [OEM] cease to be the manufacturer of a device?
When a Single-Use device has been reprocessed for re-use, either by a reprocessor or by a Hospital or Health Care Facility.
What is a Combination Product?
A product in which a medical device is used to administer a drug [RX or OTC], nutritional product, or biologic.
- EX: metered-dose inhalers, nasal spray, prefilled syringe, auto-injectors, dialysis machines.
Regarding MDR sections, what is the difference between MDR’s for a Medication [RX or OTC], and a medical device?
• Adverse Drug Event is the same 3500 form, but section C is filled out, as opposed to section D, which is for medical devices.
Which standard/regulation pertains to Medical Device Reporting?
FDA 21 CFR Part 803
Which standard/regulation deals with complaint handling?
FDA 21 CFR Part 820.198
What is a Mother-Infant/Fetus Report?
those cases in which either a mother or a fetus/breast feeding infant, or both, sustain an adverse event that the initial reporter considers possibly associated with a product administered to, or a device used on the mother during pregnancy.
When ONLY the infant/fetus has an adverse reaction/event (other than fetal death, miscarriage or abortion), the information provided in section A applies to the ______?
However, the information in section C or D would apply to the ________?
When ONLY the infant/fetus has an adverse reaction/ event (other than fetal death, miscarriage or abortion), the information provided in section A applies to the infant/ fetus. However, the information in section C or D would apply to the mother who was the source of exposure to the product or device.
For those cases describing fetal death, miscarriage or abortion, who is reported as the patient in the report?
For those cases describing fetal death, miscarriage or abortion, report the mother as the patient in the report [In Section A]?
When a newborn baby is found to have a congenital anomaly/birth defect that the initial reporter considers possibly associated with a product administered to, or device used on the mother during pregnancy, who is considered the PT being reported on?
When a newborn baby is found to have a congenital anomaly/birth defect that the initial reporter considers possibly associated with a product administered to, or a device used on the mother during pregnancy, the patient is the newborn baby.
If both the mother and the infant/fetus sustain adverse events, how many reports should be filed?
If both the mother and the infant/fetus sustain adverse events, two reports should be provided and linked using the narrative field in block B5.
What is Section E? What goes in Section E?
- Section E: Initial Reprter
- Information on who initially reported the adverse event to the user facility, importer, or device manufacturer.
What does code FDA 21 CFR 803 outline?
FDA21 803 oultines the requirements for medical device reporting
What does FDA 21 CFR 820.198 outline?
FDA 21 CFR 820.198 deals with complaint handling
What’s the European equivalent to the FDA’s 21 CFR 820.198?
ISO 13485
