FDA Adverse Event
Malfunction
Summary report: N
MEDEGEN MEDICAL PRODUCTS, LLC
MDR report key: 16775804
·
Received April 20, 2023
Report
- Report Number
- 16775804
- Event Type
- Malfunction
- Date Received
- April 20, 2023
- Date of Event
- March 15, 2023
- Report Date
- March 30, 2023
- Manufacturer
- MEDEGEN MEDICAL PRODUCTS
- Product Code
- FNY
- UDI-DI
- 10700812000300
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
UNKNOWN SPECKS NOTED INSIDE BOWL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1206767 | MEDEGEN MEDICAL PRODUCTS, LLC | BASIN, EMESIS | FNY | MEDEGEN MEDICAL PRODUCTS | 01232 | 303596 | 10700812000300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |