MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-12 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59000 manufactured by Welch Allyn.
[3008317]
Complainant stated that the lower bill of the speculum broke longitudinally during an external examination and the pt sustained a small cut that was bleeding. Complainant stated that the pt did not require any intervention to stop the bleeding. She gave the pt topical lidocaine for the discomfort. The pt did not require any post-procedural follow-up. The customer did not provide a pt identifier.
Patient Sequence No: 1, Text Type: D, B5
[10175652]
Welch allyn is reporting this event pursuant to fda's two-year reporting rule based on the original report filed on october 26, 2010. This speculum has not been returned to welch allyn. However, the complainant did provide welch allyn a photograph of the speculum. This failure mode is currently under evaluation and a follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2012-00010 |
| MDR Report Key | 2754003 |
| Report Source | 05,06 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-08-23 |
| Date of Event | 2012-08-23 |
| Date Mfgr Received | 2012-08-23 |
| Date Added to Maude | 2012-12-27 |
| 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 STREET ROAD P.O. 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 | 2012-09-12 |
| Model Number | 59000 |
| Catalog Number | 59000 |
| Lot Number | UNKNOWN |
| 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 STREET ROAD SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-12 |