MAUDE Adverse Event Report: BECKER ORTHOPEDIC APPLIANCE CO. MAPLE LEAF; JOINT, HIP, EXTERNAL BRACE

Model Number 146-S

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pressure Sores (2326)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

Pressure ulcer developed on the posterior right leg located under the brace.Back of the brace was noted to be hard and applied pressure to the thigh.

• Brand Name: MAPLE LEAF
• Type of Device: JOINT, HIP, EXTERNAL BRACE
• Manufacturer (Section D): BECKER ORTHOPEDIC APPLIANCE CO.; 635 executive drive; troy MI 48083
• MDR Report Key: 7983914
• MDR Text Key: 124343459
• Report Number: 7983914
• Device Sequence Number: 1
• Product Code: ITS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 146-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other