MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-12 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn.
[75101277]
The customer did not provide a lot number therefore welch allyn was unable to review the device history record for the speculum. As the device and packaging was disposed of by the user we were unable to determine if this was a single rail or double rail speculum. Fourteen representative samples were returned to welch allyn for evaluation. The specula were a mix of single rail and double rail specula. Upon visual inspection of all 14 returned specula no damage was observed. Microscopic examination of the single rail specula showed no damage or cracking. The single rail specula were last manufactured on 30 july 2014. The enhanced double wall specula design was introduced in august 2014. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[75101278]
Welch allyn received a report stating, kleenspec 590 series disposable vaginal speculum broke while being used on a patient during a pelvic exam. The speculum was examined by the physician prior to use and no visible cracks were noted. The physician inserted the speculum into the patient's vagina and immediately upon opening of the speculum, the upper blade shattered. Approximately half of the left side of the upper blade broke off of the speculum. The broken pieces were removed from the patient's vagina. The patient sustained an approximate 1 to 2 cm vaginal wall laceration from the sharp edge of the broken blade. Pressure was applied and the bleeding subsided. The patient recovered without further treatment or incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316463-2017-00004 |
| MDR Report Key | 6562897 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-12 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-05-12 |
| 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 | MR. EDWARD O'NEIL |
| Manufacturer Street | 4341 STATE STREET ROAD P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3155544055 |
| 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 | 2017-05-12 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET ROAD P.O. BOX 220 SKANEATELES FALLS NY 131530220 US 131530220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-12 |