MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-07-09 for VACURETTE CANNULA, BERKELEY CURVED 9 MM 21552 manufactured by Acmi Corporation.
[389331]
Pt was having a d&c procedure. With rotation of the suction curette, the catheter tip broke off inside pt. Causing uterine perforation. Pt. Not require follow up procedure to repair. There is no injury or adverse effect to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-2004-00012 |
| MDR Report Key | 595617 |
| Report Source | 00 |
| Date Received | 2004-07-09 |
| Date of Report | 2004-07-08 |
| Date of Event | 2003-12-02 |
| Date Facility Aware | 2003-12-03 |
| Report Date | 2004-07-08 |
| Date Reported to FDA | 2004-02-06 |
| Date Mfgr Received | 2004-05-20 |
| Date Added to Maude | 2005-04-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | JOHN RING, JR. |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 017722104 |
| Manufacturer Country | US |
| Manufacturer Postal | 017722104 |
| Manufacturer Phone | 5088042697 |
| Manufacturer G1 | ACMI CORP |
| Manufacturer Street | 3037 MT.PLEASANT STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VACURETTE CANNULA, BERKELEY CURVED 9 MM |
| Generic Name | CURETTE |
| Product Code | HHK |
| Date Received | 2004-07-09 |
| Model Number | 21552 |
| Catalog Number | 21552 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 585443 |
| Manufacturer | ACMI CORPORATION |
| Manufacturer Address | * RACINE WI * US |
| Baseline Brand Name | BERKELEY VACURETTE CANNULA, CURVED |
| Baseline Generic Name | CURVED TIP CURETTE |
| Baseline Catalog No | 21552 |
| Baseline ID | CURVED TIP VACU |
| 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 | 2004-07-09 |