MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-09 for UTERINE CORKSCREW 7655MB manufactured by Wisap.
[10661]
The myoma drill, which previously was a two part stainless steel device, with the screw part fixed to the rod part, is now a single rod part, with the distal tip machined to a screw action. A separation, such as the reported event, will thus be prevented.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001895 |
| MDR Report Key | 13140 |
| Date Received | 1994-05-09 |
| Date of Report | 1994-04-28 |
| Date of Event | 1994-02-07 |
| Date Added to Maude | 1994-05-10 |
| 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 |
| 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 | UTERINE CORKSCREW |
| Generic Name | UTERINE CORKSCREW |
| Product Code | HHO |
| Date Received | 1994-05-09 |
| Catalog Number | 7655MB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13138 |
| Manufacturer | WISAP |
| Manufacturer Address | TOMBALL TX 77375 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-05-09 |