MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-18 for CABOT MEDICAL FLEXIBLE TIP VACURETTE, 7 MM manufactured by Cabot Medical.
[21297]
Pt having therapeutic abortion procedure under local anesthesia. Flexible curette tip broke off. Physician unable to retrieve broken tip. Pt taken to surgery for hysterectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 29937 |
| MDR Report Key | 29937 |
| Date Received | 1996-01-18 |
| Date of Report | 1995-11-26 |
| Date of Event | 1995-10-26 |
| Date Facility Aware | 1995-10-28 |
| Report Date | 1995-11-26 |
| Date Added to Maude | 1996-02-13 |
| 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 | CABOT MEDICAL FLEXIBLE TIP VACURETTE, 7 MM |
| Generic Name | FLEXIBLE TIP VACURETTE, 7 MM |
| Product Code | HHK |
| Date Received | 1996-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31032 |
| Manufacturer | CABOT MEDICAL |
| Manufacturer Address | 2021 CABOT BLVD W. LANGHORNE PA 19047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-01-18 |