MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-18 for LEAD APRON NI manufactured by Davis Lead Aprons.
[80570]
Eight lead aprons and 8 thyroid shields found to be contaminated. Has had devices since end of last year.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011731 |
| MDR Report Key | 106317 |
| Date Received | 1997-07-18 |
| Date of Report | 1997-07-18 |
| Date of Event | 1997-07-01 |
| Date Added to Maude | 1997-07-21 |
| 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 | PHYSICIST |
| 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 | LEAD APRON |
| Generic Name | LEAD APRON |
| Product Code | EAJ |
| Date Received | 1997-07-18 |
| 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 | 104536 |
| Manufacturer | DAVIS LEAD APRONS |
| Manufacturer Address | 3715 ALOA ST. HOUSTON TX 77018 US |
| Brand Name | THYROID SHIELD |
| Generic Name | THYROID SHIELD |
| Product Code | KPY |
| Date Received | 1997-07-18 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 2 |
| Device Event Key | 104545 |
| Manufacturer | DAVIS LEAD APRONS |
| Manufacturer Address | 3715 ALOA ST. HOUSTON TX 77018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-18 |