MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-16 for SKLAR BLUE UNK 91-5014 manufactured by Sklar Instruments.
[197524]
Burns occurred to the vaginal lining of the pt during a leep procedure. Bovie used was checked and found to be functioning appropriately. Speculum used has an insulated coating in all areas except the tightening screw.
Patient Sequence No: 1, Text Type: D, B5
[223298]
Add'l info rec'd from mfr 4/24/01: mfr has requested copies of all of the documentation generated from the incident. Once mfr is in receipt of this info it will investigate the matter without the device. The device is being held at the hosp and is not available to mfr for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021355 |
| MDR Report Key | 321378 |
| Date Received | 2001-03-16 |
| Date of Event | 2001-02-28 |
| Date Added to Maude | 2001-03-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKLAR BLUE |
| Generic Name | VAGINAL SPECULUM, SKLER BLUE |
| Product Code | HDF |
| Date Received | 2001-03-16 |
| Model Number | UNK |
| Catalog Number | 91-5014 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 310920 |
| Manufacturer | SKLAR INSTRUMENTS |
| Manufacturer Address | 889 S MATLACK ST WEST CHESTER PA 19382 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-03-16 |