MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-06-26 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn.
[20718100]
The customer stated that a medium sized speculum had broken during a procedure. The customer states that the speculum was inserted into a patient and broke during use. When the item broke the patient sustained a cut. There was slight bleeding from the cut, however the patient did not require medical attention. The customer did not provide a patient identifier.
Patient Sequence No: 1, Text Type: D, B5
[20898416]
Welch allyn is reporting this in an abundance of caution. The device evaluation is not yet complete. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2013-00009 |
| MDR Report Key | 3205399 |
| Report Source | 06 |
| Date Received | 2013-06-26 |
| Date of Report | 2013-05-31 |
| Date of Event | 2013-05-31 |
| Date Mfgr Received | 2013-05-31 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-09-19 |
| 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 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 | 2013-06-26 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| Lot Number | 183346 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-06-26 |