MAUDE Adverse Event Report: MUELLER SPORTS MEDICINE, INC. MUELLER ADJUSTABLE ANKLE SUPPORT

Model Number 4547

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Reaction (2414)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4 ): mueller sports medicine has reported this complaint voluntarily based on the issue of potential serious injury that could have been the result of the product coming in contact with consumers skin causing a skin reaction.Numberous attempts were made to gather more information from consumer without any success.This issue will be monitored through the complaints and capa system within mueller's quality management system.Complaint has been closed with no further action or investigation at this time.Classification: class i exempt.

Event Description

Customer bought product from (b)(6) because the carton said latex free materials.She wore it for 2 days and had an extreme reaction that is similar to the one that she gets from latex.Numerous attempts to contact consumer did not produce additional information.

• Brand Name: MUELLER ADJUSTABLE ANKLE SUPPORT
• Type of Device: ADJUSTABLE ANKLE SUPPORT
• Manufacturer (Section D): MUELLER SPORTS MEDICINE, INC.; prairie du sac WI
• Manufacturer Contact: 1 quench dr.; prairie du sac, WI 53578 ; 6086438530
• MDR Report Key: 5366379
• MDR Text Key: 36028477
• Report Number: 2110420-2015-00001
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4547
• Device Catalogue Number: 4547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention