MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-21 for * TS-2 R - WITH RING ATTACHMENT manufactured by Burlington Medical Supplies.
[71863]
In response to the advisory, all leaded radiation protection devices were evaluated for radioactive contamination using a ludlum 14 c survey meter with a ludlum model 44-9 pancake probe. One contaminated device was found. The survey results are. 5 mr/hr at the surface. The supplier will be contacted by phone to discuss a replacement device and return shipping arrangements.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011961 |
| MDR Report Key | 115767 |
| Date Received | 1997-08-21 |
| Date Added to Maude | 1997-08-28 |
| 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 | * |
| Generic Name | THYROID PROTECTIVE COLLAR |
| Product Code | KPY |
| Date Received | 1997-08-21 |
| Model Number | TS-2 R - WITH RING ATTACHMENT |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 113597 |
| Manufacturer | BURLINGTON MEDICAL SUPPLIES |
| Manufacturer Address | 3 ELMHURST ST. NEWPORT VA 23603 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-21 |