MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-16 for UNK manufactured by Unk.
[437706]
In 2005, during a d&c hysteroscopy, physician passed a sharp curette in a to and from motion to curette the entire endometrial cavity until the cri uteri was noted. The curette was felt at one point to pass greater than the nine cms that the uterus had sounded per uterine sound dilators. At that time uterus was felt to perforated. Perforation site was inspected with no evidence of active bleeding. Pt was watched for ten mins with no active bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 690058 |
| MDR Report Key | 690058 |
| Date Received | 2006-03-16 |
| Date of Report | 2006-03-14 |
| Date of Event | 2005-12-08 |
| Date Facility Aware | 2006-03-09 |
| Report Date | 2006-03-14 |
| Date Reported to FDA | 2006-03-14 |
| Date Added to Maude | 2006-03-22 |
| 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 |
| 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 | UNK |
| Generic Name | SHARP CURETTE |
| Product Code | HCY |
| Date Received | 2006-03-16 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 679226 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-16 |