MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-25 for KLEENSPEC VAGINAL SPECULA ILLUMINATION IPX7 * manufactured by Welch Allyn.
[2818092]
Kleenspec vaginal specula illumination system was used as a light source for illumination without the plastic speculum. The light bulb becomes warm, to hot to the touch at the tip of the bulb while the sides remain cool to touch providing no indication the bulb gets as hot as it does.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2653892 |
| MDR Report Key | 2653892 |
| Date Received | 2012-06-25 |
| Date of Report | 2012-06-25 |
| Date of Event | 2012-03-27 |
| Report Date | 2012-06-25 |
| Date Reported to FDA | 2012-06-25 |
| Date Added to Maude | 2012-07-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLEENSPEC VAGINAL SPECULA ILLUMINATION |
| Generic Name | VAGINAL SPECULUM LIGHT |
| Product Code | HIB |
| Date Received | 2012-06-25 |
| Model Number | IPX7 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 2 YRS |
| 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 | 2012-06-25 |