MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-29 for TENACULUM manufactured by Unk.
[904093]
During laparoscopic tubal ligation sims retractor was placed into the anterior cervix and with a tenaculum the posterior cervical lip was graft. The tenaculum tore through the tissue causing a laceration of the posterior vaginal wall close to the cervical vaginal junction approx 2cm which caused bleeding. The laceration was repaired using a 2-0 vicryl with interrupted sutures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007821 |
| MDR Report Key | 1084304 |
| Date Received | 2008-07-29 |
| Date of Report | 2008-07-29 |
| Date of Event | 2008-06-03 |
| Date Added to Maude | 2008-08-06 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TENACULUM |
| Product Code | HDC |
| Date Received | 2008-07-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1063097 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-07-29 |