MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-26 for ALIMED, INC. * X91-202 manufactured by B.t. Medical.
[92113]
On 7/10/97 - notice of alert from u. S. Regulatory commission re: the possibility of shielding products containing lead to be contaminated with small amounts of naturally occurring radioactive material. The hosp. Tested two aprons and found them to have low level radiation contamination. The aprons were returned to the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 122313 |
| MDR Report Key | 122313 |
| Date Received | 1997-09-26 |
| Date of Report | 1997-07-29 |
| Date of Event | 1997-07-23 |
| Report Date | 1997-07-29 |
| Date Reported to FDA | 1997-07-30 |
| Date Reported to Mfgr | 1997-07-30 |
| Date Added to Maude | 1997-09-29 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALIMED, INC. |
| Generic Name | LEAD APRONS (2) |
| Product Code | EAJ |
| Date Received | 1997-09-26 |
| Returned To Mfg | 1997-07-23 |
| Model Number | * |
| Catalog Number | X91-202 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 119794 |
| Manufacturer | B.T. MEDICAL |
| Manufacturer Address | 2ND & DEPOT ST. BRIDGEPORT PA 19405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-09-26 |