MAUDE Adverse Event Report: UNK. MULTIPODUS BOOT; CONTRACTURE BOOT

Model Number 537257

Device Problem Material Integrity Problem (2978)

Patient Problem Pressure Sores (2326)

Event Date 01/12/2015

Event Type  Other  

Event Description

Pressure area from shear/friction of multipodus/contracture boot.The problem may have been improperly fastened/ placed on.

• Brand Name: MULTIPODUS BOOT
• Type of Device: CONTRACTURE BOOT
• Manufacturer (Section D): UNK.; unk
• MDR Report Key: 4465999
• MDR Text Key: 19799853
• Report Number: MW5040437
• Device Sequence Number: 1
• Product Code: ITW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 537257
• Device Catalogue Number: 537257
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 81