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

Model Number 11194

Device Problem Material Separation (1562)

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

Event Date 04/14/2014

Event Type  malfunction  

Event Description

Report the sole separating from the shoe on a post op shoe after 2 weeks.No injury was reported.

Manufacturer Narrative

Product has not arrived for investigation.This is a known failure mode.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.

• 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; carlsbad CA 92010
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955823
• MDR Report Key: 3784753
• MDR Text Key: 4440612
• Report Number: 2028253-2014-00011
• 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: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11194
• Device Catalogue Number: 11194
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2014
• Initial Date FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1