FDA Adverse Event
Malfunction
Summary report: N
WET SKIN SCRUB TRAY
MDR report key: 11952
·
Received March 11, 1994
Report
- Report Number
- MW1001024
- Event Type
- Malfunction
- Date Received
- March 11, 1994
- Report Date
- March 10, 1994
- Manufacturer
- PROFESSIONAL MEDICAL PRODUCTS, INC.
- Product Code
- GEC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THREE HUMAN HAIRS OF DIFFERENT TEXTURE WERE FOUND ON TRAYS IN TWO SEALED, STERILE WRAPPED PACKAGES. TWO OF THE HAIRS WERE BETWEEN TRAYS AND ONE HAIR WAS UNDER A SPONGE IN THE TRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WET SKIN SCRUB TRAY | GEC | PROFESSIONAL MEDICAL PRODUCTS, INC. | 512561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |