MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-14 for UNKNOWN-CLAIMED TO BE WOLFF SYSTEM * manufactured by Osram Sylvania, Inc..
[36230]
Customer attended an initial indoor tanning session on 5/4/93, customer claims a condition of "iritis". Wolff system technology is notified on 11/26/96.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1054665-1996-00020 |
| MDR Report Key | 57240 |
| Date Received | 1996-12-14 |
| Date of Report | 1996-12-13 |
| Date of Event | 1991-05-04 |
| Date Reported to FDA | 1996-12-13 |
| Date Reported to Mfgr | 1996-12-13 |
| Date Added to Maude | 1996-12-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN-CLAIMED TO BE WOLFF SYSTEM |
| Generic Name | CLAIMED TO BE A LOW PRESSURE UV LAMP |
| Product Code | FTC |
| Date Received | 1996-12-14 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 57737 |
| Manufacturer | OSRAM SYLVANIA, INC. |
| Manufacturer Address | 100 ENDICOTT ST DANVERS MA 01923 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-14 |