MAUDE Adverse Event Report: BREG, INC. WALKER GENESIS 4 STRP GRAY L

Model Number BL514007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Product is not expected to be returned for evaluation.No indication of malfunction or product failing to meet its intended use.A review of internal files form date of incident to date of this report identified no other reports for this alleged incident.Patient was provided with full instructions on the proper use and application of the product, including plan of care for diabetic condition.

Event Description

Breg received a report alleging a patient had a toe amputated after wearing a walker boot.Patient was prescribed a walker boot after reporting left ankle pain and told to wear the boot for 6 weeks.After approximately 5 weeks a small callus was observed and the boot was replaced with a different walker boot that was worn for approximately 4 weeks.Approximately four months after the replacement of the initial boot, the patient was admitted to the emergency room and had his toe amputated.

• Brand Name: WALKER GENESIS 4 STRP GRAY L
• Type of Device: WALKER GENESIS 4 STRP GRAY L
• 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: eduardo blanco ; 2882 loker avenue east; carlsbad, CA 92010 ; 7607955906
• MDR Report Key: 13831115
• MDR Text Key: 287525086
• Report Number: 2028253-2022-00002
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BL514007
• Device Catalogue Number: BL514007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 104 KG