MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-25 for XENOLITE 630VS * manufactured by Lite-tech, Inc..
[18561533]
Three contaminated leaded shields were recently discovered at facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012044 |
| MDR Report Key | 118411 |
| Date Received | 1997-08-25 |
| Date Added to Maude | 1997-09-11 |
| 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 | XENOLITE |
| Generic Name | VEST, SKIRT & THYROID SET |
| Product Code | KPY |
| Date Received | 1997-08-25 |
| Model Number | 630VS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 116111 |
| Manufacturer | LITE-TECH, INC. |
| Manufacturer Address | 2ND AND DEPOT ST BRIDGEPORT PA 19405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-25 |