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 |