MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-25 for ERGOLITE PROTECTIVE APRON UNK manufactured by Aadco Medical, Inc..
[111300]
The kilt is too small to provide appropriate shielding over the front and sides of the body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014055 |
| MDR Report Key | 174020 |
| Date Received | 1998-06-25 |
| Date of Report | 1998-06-25 |
| Date Added to Maude | 1998-06-29 |
| 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 | ERGOLITE PROTECTIVE APRON |
| Generic Name | XYL KILT |
| Product Code | KPY |
| Date Received | 1998-06-25 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | ITEM # LP-X685C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 169190 |
| Manufacturer | AADCO MEDICAL, INC. |
| Manufacturer Address | P.O. BOX 410 RANDOLPH VT 05060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-06-25 |