MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-12 for WOLFF SYSTEM EUROSUN S 3 ES3-73-RDC * manufactured by Osram Sylvania, Inc..
[23849]
Client received a "reddish-stripe" down the mid section of her back. Approx. 1 to 2 inches wide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1054665-1996-00018 |
| MDR Report Key | 36052 |
| Date Received | 1996-08-12 |
| Report Date | 1996-08-12 |
| Date Added to Maude | 1996-08-30 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WOLFF SYSTEM EUROSUN S 3 |
| Generic Name | LOW PRESSURE FLUORESCENT ULTRAVIOLET PUMP |
| Product Code | FTC |
| Date Received | 1996-08-12 |
| Model Number | ES3-73-RDC |
| Catalog Number | * |
| Lot Number | 1991 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 37474 |
| Manufacturer | OSRAM SYLVANIA, INC. |
| Manufacturer Address | 100 ENDICOTT STREET DANVERS MA 01923 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-08-12 |