MAUDE Adverse Event Report: BREG, INC. BREG POST-OP SHOE

Model Number 11193

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

The evaluation has confirmed separation of the sole from the shoe.The supplier of the post-op shoe has been issued a corrective action and has been unable to determine the root cause of the failure.Breg is no longer distributing this product.

Event Description

Sole separated from base of shoe.No injury reported.

• Brand Name: BREG POST-OP SHOE
• Type of Device: POST-OP SHOE
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; car;lsbad CA 92010
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955823
• MDR Report Key: 5066631
• MDR Text Key: 26017320
• Report Number: 2028253-2015-00004
• 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
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11193
• Device Catalogue Number: 11193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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