FDA Adverse Event
Malfunction
Summary report: N
EXACT MEDICAL MANUFACTURING, INC.
MDR report key: 20999979
·
Received December 23, 2024
Report
- Report Number
- 20999979
- Event Type
- Malfunction
- Date Received
- December 23, 2024
- Date of Event
- November 21, 2024
- Report Date
- December 18, 2024
- Manufacturer
- EXACT MEDICAL MANUFACTURING, INC.
- Product Code
- KKX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE MICROSCOPE LENS POPS OUT WHEN OPENING THE DRAPE. REF # DR650. 2 DRAPES WITH THE SAME LOT REMOVED FROM THE ROOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79574 | EXACT MEDICAL MANUFACTURING, INC. | DRAPE, SURGICAL | KKX | EXACT MEDICAL MANUFACTURING, INC. | DR650 | 2407E190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |