MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-05 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn, Inc..
[21847029]
Welch allyn distributor informed welch allyn of a customer who had a vaginal speculum break in the patient and claims injury. On (b)(6) 2014 the emergency room physician performed a routine pap smear test on (b)(6) patient. Upon opening the speculum, the bill broke in half. The physician removed the broken piece and noted a tear in the vaginal tissue with some bleeding. No treatment was required at that time for the tear. The patient was instructed to follow up with her gynecologist. The emergency room physician called the patient on (b)(6) 2014 and was told by the patient that she returned to a different emergency department for treatment of a uti and vaginitis and upon exam was informed that the tear was healing. No treatment for tear was necessary by secondary hospital, as well.
Patient Sequence No: 1, Text Type: D, B5
[22222059]
Welch allyn is reporting this in abundance of caution. The customer did not return the device to welch allyn, but completed a questionnaire with a drawing of a vaginal speculum device indicating the break location and manner in which the vaginal speculum broke. The questionnaire and marked-up picture was reviewed by welch allyn engineering and the failure mode matches one that has been previously investigated. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2014-00010 |
| MDR Report Key | 4268456 |
| Report Source | 07 |
| Date Received | 2014-11-05 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-09-29 |
| Date Mfgr Received | 2014-10-10 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-11-26 |
| 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 |
| Generic Name | VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2014-11-05 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| Lot Number | 228071 |
| 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, INC. |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-05 |