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  

Event Description

Pt had a rotator cuff repair and biceps tenodesis and was fitted postoperatively with a berg slingshot shoulder immobilizer with abduction pillow.By 10 days post op there was hyperesthesia reported in forearm.Subsequently there is emg evidence of nerve compression injury.The patient is unable to flex ip joint of thumb, is in constant pain, and can no longer return to previous employment as keyboardist.Fda safety report id# (b)(4).

• Brand Name: BREG SLINGSHOT SHOULDER IMMOBILIZER
• Type of Device: SLING, ARM
• Manufacturer (Section D): BREG, INC.
• MDR Report Key: 14021576
• MDR Text Key: 288809716
• Report Number: MW5108786
• Device Sequence Number: 1
• Product Code: ILI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White