MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-06 for ACMI VACURETTE CURETTE UNK manufactured by Acmi Corp.
[366938]
Pt was having d&c procedure. With rotation of the suction curette, the catheter tip broke off inside pt causing uterine perforation. Piece was retrieved. Pt did not require follow up procedure to repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031136 |
| MDR Report Key | 512919 |
| Date Received | 2004-02-06 |
| Date of Report | 2004-02-06 |
| Date of Event | 2003-12-02 |
| Date Added to Maude | 2004-02-27 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACMI |
| Generic Name | VACURETTE CURETTE |
| Product Code | FZS |
| Date Received | 2004-02-06 |
| Model Number | VACURETTE CURETTE |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 501926 |
| Manufacturer | ACMI CORP |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-06 |