MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER CAST VAC; INSTRUMENT, CAST REMOVAL, AC - POWERED

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 10/02/2018

Event Type  Injury  

Event Description

(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.

• Brand Name: STRYKER CAST VAC
• Type of Device: INSTRUMENT, CAST REMOVAL, AC - POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 7938771
• MDR Text Key: 123229958
• Report Number: MW5080391
• Device Sequence Number: 1
• Product Code: LGH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 32