MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-07-06 for UNIVERSAL ACTIVE CORD ACU-1-VL manufactured by Wilson-cook Medical, Inc..
[21960959]
During use of a wilson-cook universal active cord, the user noted that the connection to an accessory device was not secure. The electrical insert in the active cord has recessed, prohibiting proper connection with athe accessory device. Another active cord was used to complete the procedure. An injury to the patient did not occur.
Patient Sequence No: 1, Text Type: D, B5
[21988934]
We were unable to confirm the report as it was described because the affected device was not returned to wilson cook for evaluation. After a review of the deivce history record for this device, we can report that no discrepancies or anomalies were observed. We were unable to conduct a sample test from this lot, because the device had been previously distributed. Conclusion were were unable to conduct a full investigation, because the affected device was not returned to wilson cook for evalustion. We can provide the following comments: the estimated number of use for this device experienced prior to this occurrence is unk. Because this device is reusable, it is possible this occurred after several uses. The useful life of a reusable device is dependant, in large part, upon the care exercised by the user during use and general handling. This device was not invoiced to the usere on december 2004. Wilson cook received the report on june 2005. Corrective actions: no corrective action warranted at this time; the appropriate personnel have been notified for their awareness. Prior to distribution, all universal active cords are subjeted to a visual and functional inspection to ensure device integrity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037905-2005-00068 |
| MDR Report Key | 735701 |
| Report Source | 06,07 |
| Date Received | 2005-07-06 |
| Date of Report | 2005-06-06 |
| Date Mfgr Received | 2005-06-06 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2006-07-19 |
| 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 | 2005-07-06 |
| Model Number | NA |
| Catalog Number | ACU-1-VL |
| Lot Number | W1998832 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 723591 |
| 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 | 2005-07-06 |