MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-29 for UNK CAST CUTTER/VAC manufactured by Stryker Instruments Kalamazoo.
[3814946]
It was reported that an unknown cast cutter/vac was used to remove a cast from a patient with club feet. The cast needed to be removed to make sure there was no open fracture. Following the removal of the cast, it was noticed that there was a small abrasion on the right medial malleolus. The doctor inspected the abrasion and determined that it was minor. The affected area was cleaned, bacitracin was applied and a bandaid was placed on the area. No further information has been provided by the customer account.
Patient Sequence No: 1, Text Type: D, B5
[11032751]
The device is not available for evaluation at this time, if additional information becomes available and the device is returned, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2012-04135 |
| MDR Report Key | 3340770 |
| Report Source | 06 |
| Date Received | 2012-11-29 |
| Date of Report | 2012-10-29 |
| Date of Event | 2012-09-16 |
| Date Mfgr Received | 2012-10-29 |
| Date Added to Maude | 2013-09-12 |
| 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 | CHELSEA CULLEN |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK CAST CUTTER/VAC |
| Generic Name | UNK |
| Product Code | LGH |
| Date Received | 2012-11-29 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-29 |