MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-21 for GOWN UNKNOWN manufactured by Safetec Of Americal, Inc..
[7968]
The rptr stated that the co is transporting gowns across interstate commerce lines that should by 510k authorized without any 510k authorization numbers. The gowns are sold for the purpose of preventing disease.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001163 |
| MDR Report Key | 12142 |
| Date Received | 1994-03-21 |
| Date of Report | 1994-03-17 |
| Date Added to Maude | 1994-03-22 |
| 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 | GOWN |
| Product Code | FYC |
| Date Received | 1994-03-21 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 12142 |
| Manufacturer | SAFETEC OF AMERICAL, INC. |
| Manufacturer Address | N TONAWANDA NY 14120 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-21 |