MAUDE Adverse Event Report: 2110420 MUELLER WRIST BRACE

Model Number 222

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2018

Event Type  Injury  

Event Description

Consumer claims brace has been problematic.

• Brand Name: MUELLER WRIST BRACE
• Type of Device: MUELLER WRIST BRACE
• Manufacturer (Section D): 2110420; one quench drive; po box 99; prarie du sac 53578
• Manufacturer (Section G): MUELLER SPORTS MEDICINE; one quench drive; po box 99; prarie du sac 53578
• Manufacturer Contact: erin daly ; one quench drive; po box 99; prarie du sac 53578 ; 6086438530
• MDR Report Key: 7401249
• MDR Text Key: 104530806
• Report Number: 2110420-2017-00001
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 222
• Device Catalogue Number: 222
• Device Lot Number: 000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR