MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-03 for STAINLESS STEEL BLADE 0940025000 manufactured by Stryker Ireland Ltd..
[21368641]
It was reported that while removing a padded fibreglass cast, the pt received a cut on the lower leg. It was also reported that the size of the cut was one inch long and was not severe. It was further reported that medical intervention was not required.
Patient Sequence No: 1, Text Type: D, B5
[21534801]
The cast cutter blade associated with this event was returned to the manufacturer for evaluation. It was visually confirmed that all teeth were intact and there was no signs of damage to the blade. The returned blade was measured where possible and all critical specifications were met. Lot number information has not been provided to permit further investigation. The ifu for the cast cutter blade has a warning which states "cut with an up and down motion as shown. Straight cutting may cut or burn the pt". The investigation results indicate that the user may have contributed to this event, however this cannot be confirmed. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2011-00128 |
| MDR Report Key | 2196642 |
| Report Source | 07 |
| Date Received | 2011-08-03 |
| Date of Report | 2011-07-07 |
| Date of Event | 2011-07-06 |
| Date Mfgr Received | 2011-07-07 |
| Date Added to Maude | 2011-08-22 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | UNA BARRY |
| 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 | 2011-08-03 |
| Returned To Mfg | 2011-07-18 |
| Catalog Number | 0940025000 |
| Lot Number | UNK |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2011-08-03 |