MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-10-01 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59000 manufactured by Welch Allyn.
[18065934]
The customer stated that the vaginal specula broke while being used on a patient during a gyn exam and lacerated the patient's vagina. Per the health care provider, the laceration was small, less than 1cm in length within the vagina. Bleeding was stopped with pressure - no suture needed. The patient was scheduled again in 3 days to follow-up and laceration was healing. The customer did not provide any patient information.
Patient Sequence No: 1, Text Type: D, B5
[18649882]
Welch allyn is reporting this in an abundance of caution. The actual speculum involved in the incident was returned and evaluated by welch allyn. The speculum was evaluated by welch allyn. The speculum was examined by engineering, and the failure mode matches one that has been previously investigated. The root cause of these very rare failures was determined to be related to potential impacts or loads on the shipping containers during transit or storage. No further investigation will be performed. Conclusion: evaluation conclusion (refer to the narrative above).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2014-00006 |
| MDR Report Key | 4189194 |
| Report Source | 01,05 |
| Date Received | 2014-10-01 |
| Date of Report | 2014-09-30 |
| Date of Event | 2014-09-03 |
| Date Mfgr Received | 2014-09-05 |
| Date Added to Maude | 2014-10-27 |
| 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, RA DIRECTOR |
| 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 |
| Generic Name | VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2014-10-01 |
| Returned To Mfg | 2014-09-23 |
| Model Number | 59000 |
| Catalog Number | 59000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2014-10-01 |