MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-07 for STAINLESS STEEL BLADE 08400402000 manufactured by Stryker Ireland Ltd..
[16195249]
The cast cutter blade associated with this event was returned to the manufacturer for evaluation. It was visually confirmed that both the blade teeth and mount were worn. Lot number information has not been provided to permit further investigation. The ifu for the cast cutter blade has a caution which states "stryker does not recommend using sst blades ref 0840-040-200, 0840-040-250 and 0940-025-000 for cutting synthetic cast material. " the investigation results indicate that the user may have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[16323608]
It was reported that while removing a padded fiberglass cast, the patient received a cut on the arm. It was also reported that a minor injury was sustained, a break in the skin. It was further reported that the wound was dressed and no other treatment was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616696-2011-00216 |
| MDR Report Key | 2379520 |
| Report Source | 07 |
| Date Received | 2011-11-07 |
| Date of Report | 2011-10-07 |
| Date of Event | 2011-10-07 |
| Date Mfgr Received | 2011-10-07 |
| Date Added to Maude | 2012-03-02 |
| 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 | UNA BERRY |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CORK |
| Manufacturer Country | EI |
| Manufacturer Phone | 214532963 |
| Manufacturer G1 | STRYKER IRELAND LTD. |
| 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 | STAINLESS STEEL BLADE |
| Product Code | LGH |
| Date Received | 2011-11-07 |
| Returned To Mfg | 2011-10-20 |
| Catalog Number | 08400402000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER IRELAND LTD. |
| Manufacturer Address | CARRIGTWOHILL, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-07 |