MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-19 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59000 manufactured by Welch Allyn.
[2939705]
Complainant stated that during an exam/during use inside a patient, a portion of the lower bill broke off inside the patient. The doctor was able to remove the piece without scratching the patient or causing any injury. The customer did not provide a patient identifier.
Patient Sequence No: 1, Text Type: D, B5
[10302523]
Welch allyn is reporting this event pursuant to fda's two-year reporting rule based on the original report filed on (b)(4) 2010. This speculum has been disposed of by the customer and therefore will not be returned to welch allyn. The failure mode as described by the complainant has been previously investigated. This device is a manually inserted, disposable vaginal speculum. 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. Method: (device discarded by customer). Results: (vaginal speculum).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2012-00011 |
| MDR Report Key | 2826677 |
| Report Source | 05,06 |
| Date Received | 2012-10-19 |
| Date of Report | 2012-10-04 |
| Date of Event | 2012-10-04 |
| Date Mfgr Received | 2012-10-04 |
| Date Added to Maude | 2013-01-31 |
| 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 |
| 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 | 2012-10-19 |
| Model Number | 59000 |
| Catalog Number | 59000 |
| 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 | 2012-10-19 |