MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-26 for UNKOWN manufactured by Unk.
[395257]
Patient in o. R for hysteroscopy, fractional dilation and curettage of uterus. The single-toothed tenaculum was placed at the anterior lip prior to sounding the uterus. After the procedure, there was noted to be a small less than. 5cm cervix laceration which was rendered hemostatic with a single suture of #3-0 vicryl and application of silver nitrate sticks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 670529 |
| MDR Report Key | 670529 |
| Date Received | 2006-01-26 |
| Date of Report | 2006-01-25 |
| Date of Event | 2005-08-29 |
| Date Facility Aware | 2006-01-25 |
| Report Date | 2006-01-25 |
| Date Reported to FDA | 2006-01-25 |
| Date Added to Maude | 2006-02-03 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | UNKOWN |
| Generic Name | SINGLE-TOOTHED TENACULUM |
| Product Code | HDC |
| Date Received | 2006-01-26 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 659839 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-26 |