MAUDE Adverse Event Report: MEDICAL TECHNOLOGY INC, (DBA BLEDSOE BRACE SYSTEMS) ARC 2.0; SHOULDER BRACE

Model Number AE050400

Device Problem Scratched Material (3020)

Patient Problem Pressure Sores (2326)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

Initial reporter: "on (b)(6) 2014, patient had surgery to replace his damaged rotator cuff w/ a titanium-alloy ball.He was immediately placed in the arc 2.0 shoulder brace.After wearing this brace day and night for approx 6 weeks, he developed a deep sore or pressure wound on his elbow the size of a quarter.The wound was the result of rubbing against the inside of the brace"."in examining the inside, i found 8 seams that were zig-zag stitched w/ industrial strength thread and a synthetic lining that wasn't very soft.Also, there was a hard lump in the elbow portion of the sling where it curved upward along the back of the arm.Upon running my finger tips over the inside of the sling, i found it to be anything but soft-to-the-touch, user friendly, and comfortable.The fabric used and the stitching are coarse and abrasive when in contact against skin over a prolonged period".Patient declined to return his device for evaluation.Investigation at the mfr of current production and finished good inventory found no "hard lump" in the elbow portion of the sling.Examination of the complaint database for this device found no other comparable complaint (creation of a "deep sore or pressure wound") and no other related reports.

Manufacturer Narrative

(b)(4).

• Brand Name: ARC 2.0
• Type of Device: SHOULDER BRACE
• Manufacturer (Section D): MEDICAL TECHNOLOGY INC, (DBA BLEDSOE BRACE SYSTEMS); grand prairie TX
• Manufacturer Contact: 2601 pinewood dr,; grand prairie, TX 75051 ; 9725227417
• MDR Report Key: 4392374
• MDR Text Key: 5432943
• Report Number: 1640524-2014-00001
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AE050400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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 Age: 75 YR
• Patient Weight: 75