MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-23 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59000 manufactured by Welch Allyn.
[2758170]
The complainant stated that on (b)(6) 2012, a small vaginal speculum broke during a pelvic exam. The nurse practitioner inserted the speculum and when she opened the speculum, the bottom bill broke into three pieces, two pieces inside the patient and the speculum. The patient did receive a small cut. Neosporin was applied and the patient is fine. The two pieces that were removed from the patient were very pointed and sharp and were thrown away in a biohazard container. The customer did not provide a pt identifier.
Patient Sequence No: 1, Text Type: D, B5
[10102899]
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 returned to welch allyn and is currently under evaluation. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2012-00008 |
| MDR Report Key | 2725550 |
| Report Source | 05,06 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-08-07 |
| Date of Event | 2012-08-07 |
| Date Mfgr Received | 2012-08-07 |
| Date Added to Maude | 2012-12-07 |
| 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 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 | 2012-08-23 |
| Returned To Mfg | 2012-08-16 |
| Model Number | 59000 |
| Catalog Number | 59000 |
| Lot Number | UNKNOWN |
| 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 ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-23 |