MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-06 for CAST CUTTER 940 manufactured by Stryker Instruments.
[5789219]
Patient was present to have a serial cast removed from her right foot. Mom was seated with patient on mat table holding her upper body while staff stabilized her right leg to remove cast. Staff began cast cutting at medial, distal foot and completed to top of the cast. When staff began cutting other side of cast (lateral aspect at toes), other staff pointed out blood dripping from cast near right medial ankle. Finished removing cast with saw as we could not see what was going on. After cutting lateral aspect of cast without incident, cast material was removed and noted laceration at right navicular. Patient's wound was cleaned, dressed and wrapped and mom took patient to ed per recommendation of therapist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4758273 |
| MDR Report Key | 4758273 |
| Date Received | 2015-05-06 |
| Date of Report | 2015-05-06 |
| Date of Event | 2015-03-26 |
| Report Date | 2015-05-06 |
| Date Reported to FDA | 2015-05-06 |
| Date Reported to Mfgr | 2015-05-08 |
| Date Added to Maude | 2015-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAST CUTTER |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2015-05-06 |
| Returned To Mfg | 2015-04-14 |
| Model Number | 940 |
| Catalog Number | 940 |
| Lot Number | N/A |
| ID Number | * |
| Device Availability | R |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 E. MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-06 |