MAUDE Adverse Event Report: BREG, INC. ARC. 2.0 SLING

Model Number AE050400

Device Problem Positioning Problem (3009)

Patient Problems Swelling (2091); Discomfort (2330); Numbness (2415)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.The application of the brace was not in accordance to the instructions for use.An in-service is being scheduled with customer to address proper application of the brace.This is the first report if this nature since the release of the product in 2015.

Event Description

The patient reported waking up with arc 2.0 sling brace applied on her arm after right shoulder surgery.The following morning she felt discomfort and noticed that the cords that are meant to tighten up the sling, were wrapped around her thumb on the inside of the sling.The patient reported receiving a blister due to the cord and initially had reported not having any sensation in her thumb.The patient later provided an update stating she has regained partial sensation in her thumb.

• Brand Name: ARC. 2.0 SLING
• Type of Device: ARC. 2.0 SLING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave east; carlsbad CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker ave east; carlsbad CA 92010
• Manufacturer Contact: carol emerson ; 2885 loker ave east; carlsbad, CA 92010 ; 7607955823
• MDR Report Key: 8903057
• MDR Text Key: 154714001
• Report Number: 2028253-2019-00003
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AE050400
• Device Catalogue Number: AE050400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other