MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-21 for WOLF UTERINE ELEVATOR * manufactured by Richard Wolf Medical Instrument.
[494195]
In 06, pt had a surgical procedure, laparoscopic bilaterial tubal fulgruation, d&c & uterine thermal ablation. A uterine elevator was put into place at the time of the procedure and then removed prior to pt's discharge. The following month , pt presented to md's office for follow up visit with the acorn tip which had remained in her vagina after the uterine elevator was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 728541 |
| MDR Report Key | 728541 |
| Date Received | 2006-06-21 |
| Date of Report | 2006-05-17 |
| Date of Event | 2006-04-26 |
| Date Facility Aware | 2006-05-10 |
| Report Date | 2006-05-17 |
| Date Added to Maude | 2006-06-27 |
| 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 |
| 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 | WOLF UTERINE ELEVATOR |
| Generic Name | UTERINE ELEVATOR |
| Product Code | HDP |
| Date Received | 2006-06-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 716838 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENT |
| Manufacturer Address | * VERNON HILLS IL 60061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-21 |