MAUDE Adverse Event Report: MUELLER SPORTS MEDICINE, INC. MUELLER REVERSIBEL THUMB STABILIZER

Model Number 62712

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Rash (2033); Reaction (2414)

Event Date 06/18/2015

Event Type  Injury  

Manufacturer Narrative

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.Good faith efforts are being made to obtain additional information.Mueller will send follow up report if additional input is received.This issue will be monitored through the complaints and capa system within mueller's quality management system.Classification: class i exempt.

Event Description

Consumer purchased at a (b)(6) and had product for approx 3 weeks.He used it daily from 10pm to 8 am according to consumer.He had a reaction after wearing thumb stabilizer after about 3 to 4 days of use.He stated he broke out in a bad rash looking like poison ivy or oak and went to a dr.

• Brand Name: MUELLER REVERSIBEL THUMB STABILIZER
• Type of Device: THUMB STABILIZER
• Manufacturer (Section D): MUELLER SPORTS MEDICINE, INC.; prairie du sac WI
• Manufacturer Contact: one quench dr.; prairie du sac, WI 53578 ; 6086438530
• MDR Report Key: 5366371
• MDR Text Key: 36030937
• Report Number: 2110420-2015-00002
• Device Sequence Number: 1
• Product Code: ILH
• 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: 01/05/2016

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: 62712
• Device Catalogue Number: 62712
• 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