MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-23 for HULKA UTERINE MANIPULATOR TENACULUM 8371.00 manufactured by Richard Wolf Gmbh.
[17800809]
A uterine perforation occurred during a laparoscopic tubal ligation procedure. The site was observed and monitored throughout the rest of the procedure. No remedial treatment of the perforation was necessary. The user facility attached no fault to the device and the device continued to be used in regular svc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 233272 |
| MDR Report Key | 233272 |
| Date Received | 1999-07-23 |
| Date of Report | 1999-06-10 |
| Date of Event | 1999-02-23 |
| Date Facility Aware | 1999-02-23 |
| Report Date | 1999-06-10 |
| Date Reported to Mfgr | 1999-06-17 |
| Date Added to Maude | 1999-07-29 |
| 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 |
| 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 | HULKA UTERINE MANIPULATOR TENACULUM |
| Generic Name | UTERINE MANIPULATOR TENACULUM |
| Product Code | HDC |
| Date Received | 1999-07-23 |
| Model Number | 8371.00 |
| Catalog Number | 8371.00 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 226110 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | HULKA TENACULUM FORCEP |
| Baseline Generic Name | UTERINE TENACULUM FORCEP |
| Baseline Model No | 8371.00 |
| Baseline Catalog No | 8371.00 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-07-23 |