MAUDE Adverse Event Report: BREG. INC. BREG T-SCOPE HIP BRACE

Model Number 08912

Device Problem Break (1069)

Patient Problem Joint Dislocation (2374)

Event Date 12/29/2013

Event Type  Injury  

Event Description

Distributor sales representative reported a patient being admitted to an emergency room with a total hip arthroplasty dislocation after having a t-scope hip brace break while getting dressed.

Manufacturer Narrative

Visual inspection indicates that the thigh sleeve fractured at the corners of the hinge bar entry location.Investigation is ongoing to establish root cause.

• Brand Name: BREG T-SCOPE HIP BRACE
• Type of Device: T-SCOPE HIP BRACE
• 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: 3607130
• MDR Text Key: 4088879
• Report Number: 2028253-2014-00003
• 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: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 08912
• Device Catalogue Number: 08912
• Device Lot Number: 231633508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 39