MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-12-08 for ION NITRIDED CAST CUTTER BLADE 0840023000 manufactured by Stryker Instruments Cork.
[1760388]
It was reported that the blade began to overheat during a serial cast removal, being used with a cast cutter handpiece. The cast extended from knee to ankle. Upon removal of the cast, slight redness and a mild abrasion was found on the pt's leg where the blade was being used to remove the cast. No additional treatment was given to the pt due to the event. No adverse consequences were reported with the event.
Patient Sequence No: 1, Text Type: D, B5
[8876585]
The blade was discarded by the account and is not available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2010-00363 |
| MDR Report Key | 1931447 |
| Report Source | 06 |
| Date Received | 2010-12-08 |
| Date of Report | 2010-11-10 |
| Date of Event | 2010-11-10 |
| Date Mfgr Received | 2010-11-10 |
| Date Added to Maude | 2012-01-18 |
| 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 | JULIE SCHOELL |
| Manufacturer Street | 4100 EAST MILHAM AVE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS CORK |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ION NITRIDED CAST CUTTER BLADE |
| Generic Name | CAST REMOVAL INSTRUMENT |
| Product Code | LGG |
| Date Received | 2010-12-08 |
| Catalog Number | 0840023000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS CORK |
| Manufacturer Address | CARRIGTWOHILL, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-08 |