MAUDE Adverse Event Report: BREG, INC KNEE ANKLE FOOT ORTHOSIS FULL

Model Number MOD-L2036

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.A review of internal files from date of incident to date identified no other reports for this alleged incident.No additional information has been provided.

Event Description

Through legal notice breg, inc.Received a report of an alleged incident involving "knee ankle foot orthosis full".The court document alleges that in or about (b)(6) 2019, the plaintiff " was using aforesaid leg brace, when suddenly, and without warning, it broke, thereby causing plaintiff to sustain serious and permanent bodily injuries, which required surgical repair".

• Brand Name: KNEE ANKLE FOOT ORTHOSIS FULL
• Type of Device: KNEE ANKLE FOOT ORTHOSIS FULL
• Manufacturer (Section D): BREG, INC; 2885 loker avenue east; carlsbad, ca
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; carlsbad, ca
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, ca ; 7955823
• MDR Report Key: 10010778
• MDR Text Key: 191860499
• Report Number: 2028253-2020-00002
• Device Sequence Number: 1
• Product Code: OHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MOD-L2036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR