MAUDE Adverse Event Report: BREG, INC. BREG JWALKER BOOT; J WALKER BOOT

Model Number BL010005

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/08/2017

Event Type  Injury  

Manufacturer Narrative

Returned boot was evaluated and sole had separated from sole.A review of the device history record revealed no non conformances or deviations during the manufacture of the boot.All release criteria were met.Incident is being investigated.

Event Description

Breg received a report from a customer of the boot sole coming off.The customer stated that the patient reported slipping and falling resulting in fractured ribs.

• Brand Name: BREG JWALKER BOOT
• Type of Device: J WALKER BOOT
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955823
• MDR Report Key: 6311813
• MDR Text Key: 66813106
• Report Number: 2028253-2017-00001
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BL010005
• Device Catalogue Number: BL010005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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