FOOT ORTHOTICS LONGITUDINAL ARCH SUPPORT L30L0-GYRTLT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-28 for FOOT ORTHOTICS LONGITUDINAL ARCH SUPPORT L30L0-GYRTLT manufactured by Langer Biomechanics.

Event Text Entries

[32635035] Aggravated "meniscus", tear in left knee.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5058191
• MDR Report Key: 5260388
• Date Received: 2015-11-28
• Date of Report: 2015-11-27
• Date of Event: 2015-11-02
• Date Added to Maude: 2015-12-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: FOOT ORTHOTICS
• Generic Name: 2 FOOT INSERTS, REMOVABLE, MOLDED TO PATIENT
• Product Code: KNP
• Date Received: 2015-11-28
• Model Number: LONGITUDINAL ARCH SUPPORT
• Catalog Number: L30L0-GYRTLT
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LANGER BIOMECHANICS

Device Sequence Number: 2

• Brand Name: FOOT ORTHOTICS
• Generic Name: 2 FOOT INSERTS, REMOVABLE, MOLDED TO PATIENT
• Product Code: KNP
• Date Received: 2015-11-28
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: LANGER BIOMECHANICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-11-28