BREG POST-OP SHOE 11194

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-02-25 for BREG POST-OP SHOE 11194 manufactured by Breg, Inc..

Event Text Entries

[3331767] A distributor reported that a breg post-op shoe (#11194) sole fell off the shoe after being used for less than 30 days. There was no injury reported and no information regarding the patient/user. The device was returned to breg for evaluation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2028253-2013-00004
• MDR Report Key: 2975722
• Report Source: 08
• Date Received: 2013-02-25
• Date of Report: 2013-01-28
• Date Mfgr Received: 2013-02-11
• Date Added to Maude: 2013-05-03
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MRS. CAROL EMERSON
• Manufacturer Street: 2885 LOKER AVENUE EAST
• Manufacturer City: CARLSBAD CA 92010
• Manufacturer Country: US
• Manufacturer Postal: 92010
• Manufacturer Phone: 7607955823
• Manufacturer G1: BREG, INC.
• Manufacturer Street: 2885 LOKER AVE. E.
• Manufacturer City: CARLSBAD CA 92010
• Manufacturer Country: US
• Manufacturer Postal Code: 92010
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BREG POST-OP SHOE
• Generic Name: POST-OP SHOE
• Product Code: IPG
• Date Received: 2013-02-25
• Model Number: 11194
• Catalog Number: 11194
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BREG, INC.
• Manufacturer Address: 2885 LOKER AVENUE EAST CARLSBAD CA 92010 US 92010

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-02-25