MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-12-15 for VACURETTE "F" TIP 8MM 10/PKG 21745 manufactured by Acmi Corporation.
[17805008]
Item perforated patient's uterus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-2003-00021 |
| MDR Report Key | 504143 |
| Report Source | 06 |
| Date Received | 2003-12-15 |
| Date of Report | 2003-12-12 |
| Date of Event | 2003-09-15 |
| Date Facility Aware | 2003-11-12 |
| Report Date | 2003-12-12 |
| Date Mfgr Received | 2003-11-12 |
| Date Added to Maude | 2004-01-06 |
| 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 "F" TIP 8MM 10/PKG |
| Generic Name | CURETTE |
| Product Code | HHK |
| Date Received | 2003-12-15 |
| Model Number | 21745 |
| Catalog Number | 21745 |
| Lot Number | 5V0053 |
| 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 | 492935 |
| Manufacturer | ACMI CORPORATION |
| Manufacturer Address | 3037 MT. PLEASANT ST. RACINE WI 53404 US |
| Baseline Brand Name | BERKELEY VACURETTES, F-TIP, 8 MM |
| Baseline Generic Name | FLEXIBLE TIP CURETTE |
| Baseline Model No | * |
| Baseline Catalog No | 21745 |
| Baseline ID | * |
| Baseline Device Family | F-TIP 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 | 2003-12-15 |