MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for VERSAGOWN (ASSURE WEAR) A69962 manufactured by Amd Medicom Inc. (amd Ritmed).
[144132128]
A new sealed bag of yellow isolation gowns has a hair inside.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8581863 |
| MDR Report Key | 8581863 |
| Date Received | 2019-05-06 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-26 |
| Report Date | 2019-04-29 |
| Date Reported to FDA | 2019-04-29 |
| Date Reported to Mfgr | 2019-05-06 |
| Date Added to Maude | 2019-05-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSAGOWN (ASSURE WEAR) |
| Generic Name | NON-SURGICAL ISOLATION GOWN |
| Product Code | OEA |
| Date Received | 2019-05-06 |
| Model Number | A69962 |
| Catalog Number | A69962 |
| Lot Number | 78905 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMD MEDICOM INC. (AMD RITMED) |
| Manufacturer Address | 6054 SHOOK ROAD, SUITE 200 LOCKBOURNE OH 43137 US 43137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-06 |