MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-01 for NONE LPA 681 VEST LPA 686 KILT manufactured by Aadco Medical Inc..
[16825312]
Nurse in the cardiac catheterization laboratory was exposed to radiation from the lead in the protective lead apron. The aprons were worn approx 30 hours. The radiation physicist stated the radiation exposure was low energy beta admitter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 106055 |
| MDR Report Key | 106055 |
| Date Received | 1997-07-01 |
| Date of Report | 1997-07-01 |
| Date of Event | 1997-06-27 |
| Date Facility Aware | 1997-06-27 |
| Report Date | 1997-07-01 |
| Date Reported to Mfgr | 1997-07-01 |
| Date Added to Maude | 1997-07-18 |
| 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 |
| 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 | NONE |
| Generic Name | WRAP AROUND LEAD VEST & KILT |
| Product Code | IWO |
| Date Received | 1997-07-01 |
| Returned To Mfg | 1997-07-01 |
| Model Number | LPA 681 VEST |
| Catalog Number | LPA 686 KILT |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 104286 |
| Manufacturer | AADCO MEDICAL INC. |
| Manufacturer Address | P.O. BOX 410 RANDOLPH VT 05060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-01 |