MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-04 for STRYKER CAST VAC manufactured by Stryker Instruments.
[123229958]
(b)(6) female patient was having a fiber glass cast removed after three weeks of wear. A stryker cast vac was used to remove the cast. The device heated during the cast removal and burned the pediatric patient? S arm. The burn was about 4 inches long and two inches wide. The skin was broken in the center of the burn and appeared white and? Oozy?. The burn was treated with antibiotic ointment and bandaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080391 |
| MDR Report Key | 7938771 |
| Date Received | 2018-10-04 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-10-02 |
| Date Added to Maude | 2018-10-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRYKER CAST VAC |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC - POWERED |
| Product Code | LGH |
| Date Received | 2018-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-10-04 |