MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-08-11 for UNIVERSAL ACTIVE CORD ACU-1-VL manufactured by Wilson-cook Medical, Inc..
[448039]
The physician used a wilson-cook universal active cord with a snare. The report indicated during the initial use the active cord did not connec securely to the snare. The procedure was completed successfully and the active cord was not reused. Post procedure the pt's condition was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2005-00080 |
| MDR Report Key | 718063 |
| Report Source | 05,06 |
| Date Received | 2005-08-11 |
| Date of Report | 2005-07-13 |
| Date of Event | 2005-07-06 |
| Date Mfgr Received | 2005-07-13 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-05-25 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MILES, MGR. |
| Manufacturer Street | 4900 BETHANIA STATION ROAD |
| Manufacturer City | WINSTON SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367740157 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL ACTIVE CORD |
| Generic Name | MISCELLANEOUS |
| Product Code | FFZ |
| Date Received | 2005-08-11 |
| Returned To Mfg | 2005-07-15 |
| Model Number | NA |
| Catalog Number | ACU-1-VL |
| Lot Number | W2079445 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 707140 |
| Manufacturer | WILSON-COOK MEDICAL, INC. |
| Manufacturer Address | 4900 BETHANIA STATION RD. WINSTON-SALEM NC 27105 US |
| Baseline Brand Name | UNIVERSAL ACTIVE CORD |
| Baseline Generic Name | MISCELLANEOUS |
| Baseline Model No | NA |
| Baseline Catalog No | ACU-1-VL |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-11 |