MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-03 for SIMPSON BASYE SPECULUM manufactured by Simpson/basye.
[20430416]
Due to a break in the integrity of the insulated surface of speculum an electrical arc caused a right vaginal wall burn during a loop excision of the cervix.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10366 |
| MDR Report Key | 10366 |
| Date Received | 1993-11-03 |
| Date of Report | 1993-11-02 |
| Date of Event | 1993-10-27 |
| Date Facility Aware | 1993-10-27 |
| Report Date | 1993-11-02 |
| Date Reported to FDA | 1993-11-02 |
| Date Reported to Mfgr | 1993-11-02 |
| Date Added to Maude | 1993-12-07 |
| 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 | SIMPSON BASYE SPECULUM |
| Generic Name | INSULATED VAGINAL SPECULUM |
| Product Code | HIC |
| Date Received | 1993-11-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10366 |
| Manufacturer | SIMPSON/BASYE |
| Manufacturer Address | 430 AYRE ST WILMINGTON DE 19804 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-11-03 |