MAUDE Adverse Event Report: EXOS LLC, A DLO, LLC COMPANY EXOS; SHORT ARM FRACTURE BRACE

Model Number 312-42-1111

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Date 08/25/2014

Event Type  Injury  

Event Description

Per 21cfr part 803, an mdr reportable event.Complaint received from patient that alleges "she was wearing the exos short arm fracture brace for 2 weeks when her skin started to fall off, she had called to report the skin irritation and someone from (b)(6) sent her the undersleeve".Questionnaire received from clinician and/or patient, "my arm is totally a different color from the rest of my arm", no indication of medical treatment required or received.Device not returned to manufacturer for evaluation.No indication event caused or contributed to permanent impairment, serious injury or death.

• Brand Name: EXOS
• Type of Device: SHORT ARM FRACTURE BRACE
• Manufacturer (Section D): EXOS LLC, A DLO, LLC COMPANY; 1122 red fox rd; arden hills MN 55112
• Manufacturer Contact: 1122 red fox rd; arden hills, MN 55112 ; 6512708471
• MDR Report Key: 4188981
• MDR Text Key: 5091629
• Report Number: 3007008525-2014-00001
• 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: Other
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 312-42-1111
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other