MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-11 for WET SKIN SCRUB TRAY 41-589 manufactured by Professional Medical Products, Inc..
[15033723]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001024 |
| MDR Report Key | 11952 |
| Date Received | 1994-03-11 |
| Date of Report | 1994-03-10 |
| Date Added to Maude | 1994-03-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WET SKIN SCRUB TRAY |
| Product Code | GEC |
| Date Received | 1994-03-11 |
| Catalog Number | 41-589 |
| Lot Number | 512561 |
| Device Expiration Date | 1996-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 11952 |
| Manufacturer | PROFESSIONAL MEDICAL PRODUCTS, INC. |
| Manufacturer Address | OCALA FL 32670 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-11 |