MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-24 for KLEENSPEC VAGINAL SPECULA 59001 manufactured by Welch Allyn.
[19974495]
Speculum cracked and broke during exam resulting in abrasion to pt's vaginal cavity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039328 |
| MDR Report Key | 4295083 |
| Date Received | 2014-11-24 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-11-21 |
| Date Added to Maude | 2014-12-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | KLEENSPEC VAGINAL SPECULA |
| Generic Name | KLEENSPEC VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2014-11-24 |
| Model Number | 59001 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | SKANEATELES FALLS 13153 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-24 |