MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-08-05 for EURO-MED 64-690 manufactured by Coopersurgical, Inc..
[326424]
During a procedure, the lower jaw broke off. The broken piece was removed manually (fingers or forceps). There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2003-00010 |
| MDR Report Key | 476155 |
| Report Source | 06 |
| Date Received | 2003-08-05 |
| Date of Report | 2003-08-05 |
| Date of Event | 2003-07-23 |
| Device Manufacturer Date | 2001-10-01 |
| Date Added to Maude | 2003-08-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EURO-MED |
| Generic Name | BIOPSY PUNCH |
| Product Code | EME |
| Date Received | 2003-08-05 |
| Returned To Mfg | 2003-07-30 |
| Model Number | 64-690 |
| Catalog Number | 64-690 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 464981 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DR. TRUMBULL CT 06611 US |
| Baseline Brand Name | EURO-MED |
| Baseline Generic Name | BIOPSY PUNCH |
| Baseline Model No | 64-690 |
| Baseline Catalog No | 64-690 |
| Baseline ID | 64-691 |
| Baseline Device Family | EURO-MED BIOPSY PUNCH |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K884740 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-08-05 |