MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-29 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59000 manufactured by Welch Allyn.
[2995948]
Complainant stated the lower bill of a small vaginal speculum broke during use. When the physician removed the two pieces that remained in the pt, the pieces were sharp and a laceration of the vaginal wall resulted. The physician could not visualize the laceration due to bleeding and removed the remaining speculum. The vaginal bleeding was described as small to moderate and the pt was given instructions to call if bleeding worsened. Two hours later, the pt called to report a slight increase in bleeding. The physician instructed her to use a tampon for pressure and offered to see her, however, she declined. The dr called the pt the next day and the bleeding had subsided. The customer did not provide a pt identifier.
Patient Sequence No: 1, Text Type: D, B5
[10198002]
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 discarded and has not been retuned to welch allyn. This failure mode is currently under eval and a follow-up report will be submitted when the eval is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2012-00007 |
| MDR Report Key | 2729503 |
| Report Source | 05,06 |
| Date Received | 2012-08-29 |
| Date of Report | 2012-08-01 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2012-08-01 |
| Date Added to Maude | 2012-12-14 |
| 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 BHMBRI, DIR |
| Manufacturer Street | 4341 STATE ST. RD. 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 | 2012-08-29 |
| Model Number | 59000 |
| Catalog Number | 59000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-08-29 |