MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-08-21 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn.
[23944895]
Welch allyn is reporting this in an abundance of caution. The customer did not return the device that broke in use to welch allyn as the device was discarded. The customer did take a photograph of the actual device that broke in use. The photograph was reviewed by welch allyn engineering and assessment of the photograph determined the failure mode matched 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. (b)(4). Not returned to manufacturer
Patient Sequence No: 1, Text Type: N, H10
[23944896]
A customer informed welch allyn of a vaginal speculum break in a patient during a pelvic exam. When the speculum was opened the lower part of the speculum broke into two pieces lengthwise. The larger part of the speculum was removed but the smaller piece of the speculum with a sharp edge was stuck on a piece of vaginal skin just distal to the vaginal opening. This was the patient right lower vaginal area, around the 7 o'clock position. Based on information from the clinician, the patient appeared to be in pain and clinched her vaginal muscles. The speculum was pushed into the vagina in attempts to get the sharp edge off of the piece of vaginal skin. A sharp piece of the speculum cut the patient's skin. The laceration was small and superficial. Patient did have bleeding but it was well controlled when pressure was applied using a scopette. Upon removal of speculum, the patient did not report any further pain. The speculum was recovered and put into a plastic bag but was accidently disposed of by the hospital. No lot or cavity number could be provided. The customer did not provide any patient information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316463-2015-00034 |
| MDR Report Key | 5020867 |
| Report Source | CONSUMER |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-04 |
| Date of Event | 2015-08-02 |
| Date Mfgr Received | 2015-08-04 |
| Date Added to Maude | 2015-08-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PEARLEY BHAMBRI |
| Manufacturer Street | 4341 STATE STREET ROAD P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156852568 |
| Manufacturer G1 | WELCH ALLYN |
| Manufacturer Street | 4341 STATE STREET ROAD |
| Manufacturer City | SKANEATELES FALLS NY 13153 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13153 |
| 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 | 2015-08-21 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET ROAD SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-21 |