MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-03-19 for VACURETTE, CURVED 10MM 10/PKG 21553 manufactured by Acmi Corporation.
[356469]
During procedure, the dr noticed that the vac was cracked and broken, discontinued use. There is no report of pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-2004-00004 |
| MDR Report Key | 536594 |
| Report Source | 06 |
| Date Received | 2004-03-19 |
| Date of Report | 2004-03-17 |
| Date of Event | 2004-02-10 |
| Date Facility Aware | 2004-02-18 |
| Report Date | 2004-03-17 |
| Date Mfgr Received | 2004-02-18 |
| Date Added to Maude | 2004-07-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN RING, JR |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 017722104 |
| Manufacturer Country | US |
| Manufacturer Postal | 017722104 |
| Manufacturer Phone | 5088042697 |
| Manufacturer G1 | ACMI CORP |
| Manufacturer Street | 3037 MT PLEASANT ST |
| 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, CURVED 10MM 10/PKG |
| Generic Name | VACUUM CURETTE |
| Product Code | HHK |
| Date Received | 2004-03-19 |
| Model Number | 21553 |
| Catalog Number | 21553 |
| Lot Number | VC00294 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 525843 |
| Manufacturer | ACMI CORPORATION |
| Manufacturer Address | 3037 MT. PLEASANT ST. RACINE WI 53404 US |
| Baseline Brand Name | BERKELEY VACUREETE CANNULAS, CURVED |
| Baseline Generic Name | CURVED TIP CURETTE |
| Baseline Catalog No | 21553 |
| 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 | 2004-03-19 |