MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for TISHLER MORGAN BIOPSY PUNCH 64-689 manufactured by Coopersurgical, Inc..
[132537910]
The complaint condition reported is currently under investigation. A follow - up report will be filed once the investigation has been completed and the findings are available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132537911]
"per customer's statement on repair authorization form " needs sharpened & repaired". (b)(4). Customer further stated concern "not closing completely and releasing while cutting tissue" as well as " not being able to release from tissue". (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00094 |
| MDR Report Key | 8209907 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2005-01-13 |
| Date Added to Maude | 2019-01-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TISHLER MORGAN BIOPSY PUNCH |
| Generic Name | TISHLER MORGAN BIOPSY PUNCH |
| Product Code | HFB |
| Date Received | 2019-01-02 |
| Model Number | 64-689 |
| Catalog Number | 64-689 |
| Lot Number | 5466 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-02 |