MAUDE Adverse Event Report: UNKNOWN; POSITIONING BOOT

Device Problem Bent (1059)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Event Description

There was a pressure ulcer noted the boot was adjusted and the pressure ulcer has since resolved.There was a metal piece on the boot that was bent improperly.The piece was adjusted back into place.

• Brand Name: UNKNOWN
• Type of Device: POSITIONING BOOT
• MDR Report Key: 4270794
• MDR Text Key: 5008512
• Report Number: MW5039195
• Device Sequence Number: 1
• Product Code: FWZ
• 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: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR