MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-08 for VACURETTE CURETTE * manufactured by Acmi Corporation.
[468206]
Patient in the operating room for suction dilatation and curettage of an incomplete miscarriage, 6-7 weeks gestation. During surgery, it was noted that the plastic suction tip (vacurette curette)had a jagged edge. The missing tip was not found upon search of the room. The doctor performed a hysteroscopy to determine if it was within the cavity and was negative. The ultrasound done in recovery room was also negative. The location of the tip is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 687608 |
| MDR Report Key | 687608 |
| Date Received | 2006-02-08 |
| Date of Report | 2006-02-08 |
| Date of Event | 2006-02-01 |
| Report Date | 2006-02-08 |
| Date Reported to FDA | 2006-02-08 |
| Date Added to Maude | 2006-03-17 |
| 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 | VACURETTE CURETTE |
| Generic Name | CANNULA, VACUUM ASPIRATION |
| Product Code | HHK |
| Date Received | 2006-02-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | VC00858 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 676815 |
| Manufacturer | ACMI CORPORATION |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-08 |