MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-13 for VAG SPECULUM 59001 79900 manufactured by Welch Allyn Holdings Inc.
[2608725]
With blades closed, a graves plastic vaginal speculum was placed and then the blades opened to expose the cervix. At that time, the interior blade cracked and broke at the base of the blade proximal to the handle. The proximal fragment broke in such a way as to create a sharp pointed edge and lacerated the right vaginal wall. The device was vag speculum manufactured by welch allyn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025133 |
| MDR Report Key | 2546264 |
| Date Received | 2012-04-13 |
| Date of Report | 2012-04-13 |
| Date of Event | 2012-03-27 |
| Date Added to Maude | 2012-04-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAG SPECULUM |
| Generic Name | VAG SPECULUM |
| Product Code | HDF |
| Date Received | 2012-04-13 |
| Model Number | 59001 |
| Catalog Number | 79900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN HOLDINGS INC |
| Manufacturer Address | 4341 STATE ST RD SKANEATELES FALLS NY 13153530 US 13153 5300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-13 |