MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-11-01 for EURO-MED 64-689 manufactured by Coopersurgical, Inc..
[705089]
During a cervical biopsy/colposcopy, a tischler morgan biopsy punch was utilized to achieve a sample. The biopsy punch cut through approx 75% and the rest was pulled off. The pt was uncomfortable and in pain. Excess bleeding occurred. The bleeding was stopped using cauterization.
Patient Sequence No: 1, Text Type: D, B5
[8117463]
The subject instrument was purchased in 2006. The instrument was returned twice for sharpening, in 2007. The instrument was returned with regards to this report. The instrument was found to be dull. It is not known how many times the instrument was used to determine if premature dulling of the cutting surface occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2007-00028 |
| MDR Report Key | 936428 |
| Report Source | 06 |
| Date Received | 2007-11-01 |
| Date of Report | 2007-11-01 |
| Date Mfgr Received | 2007-10-04 |
| Date Added to Maude | 2007-11-07 |
| 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 | 0 |
| 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 |
| 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 | 2007-11-01 |
| Model Number | 64-689 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 910545 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-01 |