MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-02 for UTERINE CURRETTE 5 UNK manufactured by Unk.
[134438]
Pt underwent suction with 8mm cannula. Gentle curettage was performed at the same time. Curettage tip broke off inside pt's uterus. Tip removed with sponge stick. No perforation occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 161128 |
| MDR Report Key | 161128 |
| Date Received | 1998-04-02 |
| Date of Report | 1998-03-26 |
| Date of Event | 1998-03-16 |
| Date Facility Aware | 1998-03-18 |
| Report Date | 1998-03-26 |
| Date Reported to FDA | 1998-03-30 |
| Date Added to Maude | 1998-04-07 |
| 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 |
| 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 | UTERINE CURRETTE |
| Generic Name | SURGICAL INSTRUMENT |
| Product Code | HCY |
| Date Received | 1998-04-02 |
| Model Number | 5 |
| Catalog Number | UNK |
| Lot Number | NONE |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 156899 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-04-02 |