MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-17 for KLEENSPEC590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn.
[5179350]
Clinician inserted a vaginal speculum into patient and noticed it was not opening normally. The speculum broke in patient with no sound of breaking plastic. The clinician noticed a broken piece of speculum upon removal from which the patient received a 1cm abrasion. F/u with the clinician indicated the patient is fine with no treatment necessary.
Patient Sequence No: 1, Text Type: D, B5
[12627239]
Welch allyn is reporting this is an abundance of caution. The returned vaginal speculum was evaluated by welch allyn engineering. The failure mode matched one that has been previously investigated and was determined to be related to damage sustained from shipping and handling. No further investigation will be performed. Evaluation conclusion(refer to the narrative above).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2014-00014 |
| MDR Report Key | 4358080 |
| Report Source | 07 |
| Date Received | 2014-12-17 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-11-21 |
| Date Mfgr Received | 2014-11-24 |
| Date Added to Maude | 2014-12-31 |
| 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,RA DIR. |
| Manufacturer Street | 4341 STATE ST. RD. P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 1315322 |
| Manufacturer Country | US |
| Manufacturer Postal | 1315322 |
| Manufacturer Phone | 3156852568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLEENSPEC590 SERIES DISP. VAGINAL SPECULA |
| Generic Name | VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2014-12-17 |
| Returned To Mfg | 2014-12-10 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| 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 | 2014-12-17 |