MAUDE Adverse Event Report: BREG, INC. BREG SLINGSHOT SHOULDER IMMOBILIZER; SLING, ARM

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

Patient Problems Nerve Damage (1979); Pain (1994); Hyperesthesia (4420)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

A review of internal complaint files from date of incident to date of this report identified no other or similar reports for this alleged incident.No investigation possible, no contact information is available, no indication that product is available for return.Unable to confirm the product involved in the alleged incident is a breg device.

Event Description

On april 29, 2022, breg inc.Received a medwatch report alleging hyperesthesia on forearm and nerve compression injury on patient's thumb from being fitted postoperatively with a breg slingshot shoulder immobilizer with abduction pillow 10 days after undergoing a rotator cuff repair and biceps tenodesis procedure.Current condition of patient is unknown.

• Brand Name: BREG SLINGSHOT SHOULDER IMMOBILIZER
• Type of Device: SLING, ARM
• 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 ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955906
• MDR Report Key: 14490830
• MDR Text Key: 292571714
• Report Number: 2028253-2022-00003
• Device Sequence Number: 1
• Product Code: ILI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability