MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-08 for BURLINGTON INDUSTRIES NI manufactured by Burlington Medical Supplies.
[16613957]
The rptr, after receiving the recall notice, was checking the appropriate equipment and found a contaminated vest. The suit consists of a vest and apron, but only the vest was contaminated. The rptr contacted the mfr and rec'd a return authorization number. The rptr still has more equipment which must be inspected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012613 |
| MDR Report Key | 136808 |
| Date Received | 1997-12-08 |
| Date of Report | 1997-12-08 |
| Date of Event | 1997-12-08 |
| Date Added to Maude | 1997-12-10 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| 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 | BURLINGTON INDUSTRIES |
| Generic Name | LEAD VEST |
| Product Code | KPY |
| Date Received | 1997-12-08 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 133645 |
| Manufacturer | BURLINGTON MEDICAL SUPPLIES |
| Manufacturer Address | 3 ELMHURST ST. NEWPORT NEWS VA 23603 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-08 |