MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2004-09-10 for COOPER SURGICAL manufactured by Coopersurgical, Inc..
[35449320]
Cooper surgical became aware of the event from a medwatch form sent from the user facility. The user facility did not identify the device on the form. This facility does not return subject devices. Attempts to positively identify the device have failed thus far. The effort to identify the device continues and f/u info will be submitted if obtained. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35449321]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2004-00013 |
| MDR Report Key | 5350308 |
| Report Source | USER FACILITY |
| Date Received | 2004-09-10 |
| Date Mfgr Received | 2004-08-13 |
| Date Added to Maude | 2016-01-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | COOPER SURGICAL |
| Generic Name | ASPIRATION NEEDLE |
| Product Code | GDM |
| Date Received | 2004-09-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DR. TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-10 |