MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-25 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn.
[2687090]
During a vaginal examination, the lower blade of the speculum broke creating a sharp, pointed edge and lacerated the pt's right vaginal wall. The condition of the pt is unknown at this time. This event was reported to the fda by the complaint. The customer did not provide a pt identifier.
Patient Sequence No: 1, Text Type: D, B5
[9834296]
This device has not been returned to welch allyn for evaluation. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2012-00003 |
| MDR Report Key | 2556665 |
| Report Source | 06 |
| Date Received | 2012-04-25 |
| Date of Report | 2012-04-05 |
| Date of Event | 2012-03-28 |
| Date Mfgr Received | 2012-04-05 |
| Date Added to Maude | 2012-09-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | PEARLEY BHAMBRI, DIRECTOR, RA |
| Manufacturer Street | 4341 STATE ST. RD. PO BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156852568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2012-04-25 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| Lot Number | 167524 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-25 |