MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-06-17 for ION NITRIDED BLADE 0940023000 manufactured by Stryker Ireland Ltd..
[19207022]
It was reported that while removing a fibreglass cast with plaster underneath, the paediatric patient received a cut to the foot and a superficial burn to the skin 1cm long from the cast cutter blade. It was also reported that the cut was repaired by the surgeon using 3-0 chromic sutures.
Patient Sequence No: 1, Text Type: D, B5
[19449838]
The castcutter blade subject to this event was not returned to the manufacturer for evaluation. Lot number information has not been provided to permit further investigation. The root cause is undetermined. 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 patient. " the cast cutter handpiece associated with this mdr is as follows; part number: 0940000000.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2011-00099 |
| MDR Report Key | 2139293 |
| Report Source | 07 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-05-23 |
| Date of Event | 2011-05-10 |
| Date Mfgr Received | 2011-05-23 |
| Date Added to Maude | 2011-06-30 |
| 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 | ION NITRIDED BLADE |
| Product Code | LGH |
| Date Received | 2011-06-17 |
| Catalog Number | 0940023000 |
| Lot Number | UNKNOWN |
| 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 IRELAND LTD. |
| Manufacturer Address | CARRIGTWOHILL, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-17 |