MAUDE Adverse Event Report: LANGER BIOMECHANICS FOOT ORTHOTICS; 2 FOOT INSERTS, REMOVABLE, MOLDED TO PATIENT

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/02/2015

Event Type  malfunction  

Event Description

Aggravated "meniscus", tear in left knee.

• Brand Name: FOOT ORTHOTICS
• Type of Device: 2 FOOT INSERTS, REMOVABLE, MOLDED TO PATIENT
• Manufacturer (Section D): LANGER BIOMECHANICS
• MDR Report Key: 5260388
• MDR Text Key: 32635035
• Report Number: MW5058191
• Device Sequence Number: 2
• Product Code: KNP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 60