MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-15 for CASTVAC W/8 FOOT HOSE AND MOBILE STAND 0986000000 manufactured by Stryker Instruments Kalmazoo.
[2348395]
It was reported that the castvac motor itself seemed to be smoking a little while cutting a cast off, so the procedure was not completed at that time since a backup device was unavailable. The case was taken off at a joint facility after a delay of five days. There were no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9308872]
The castvac has not yet been received at the manufacturer for testing. An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted if the results of the quality investigation require one.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2011-03378 |
| MDR Report Key | 2281078 |
| Report Source | 06 |
| Date Received | 2011-09-15 |
| Date of Report | 2011-08-26 |
| Date of Event | 2011-08-26 |
| Date Mfgr Received | 2011-08-26 |
| Device Manufacturer Date | 2003-12-12 |
| Date Added to Maude | 2011-11-28 |
| 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 | GREGORY GOHL |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASTVAC W/8 FOOT HOSE AND MOBILE STAND |
| Product Code | LGH |
| Date Received | 2011-09-15 |
| Catalog Number | 0986000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS KALMAZOO |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-15 |