MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-24 for VACURETTE * 20317 manufactured by Acmi Corporation.
[439206]
This disposable device was packaged as an 8mm curved vacurette. When package was opened an 8mm straight vacurette was inside.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 673723 |
| MDR Report Key | 673723 |
| Date Received | 2006-01-24 |
| Date of Report | 2006-01-24 |
| Date of Event | 2005-12-22 |
| Report Date | 2006-01-24 |
| Date Reported to FDA | 2006-01-24 |
| Date Added to Maude | 2006-02-14 |
| 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 |
| Generic Name | VACUUM ASPIRATION CURETTE |
| Product Code | HHK |
| Date Received | 2006-01-24 |
| Model Number | * |
| Catalog Number | 20317 |
| Lot Number | VC00829 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 663032 |
| Manufacturer | ACMI CORPORATION |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US |
| Baseline Brand Name | BERKELEY VACUREETE CANNULAS, CURVED |
| Baseline Generic Name | CURVED TIP CURETTE |
| Baseline Catalog No | 20317 |
| Baseline Device Family | VACURETTE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-01-24 |