MUELLER REVERSIBEL THUMB STABILIZER 62712

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-06 for MUELLER REVERSIBEL THUMB STABILIZER 62712 manufactured by Mueller Sports Medicine, Inc..

Event Text Entries

[36030937] 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.
Patient Sequence No: 1, Text Type: N, H10


[36030938] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2110420-2015-00002
MDR Report Key5366371
Report SourceCOMPANY REPRESENTATIVE
Date Received2016-01-06
Date of Report2016-01-05
Date of Event2015-06-18
Date Added to Maude2016-01-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetONE QUENCH DR.
Manufacturer CityPRAIRIE DU SAC WI 53578
Manufacturer CountryUS
Manufacturer Postal53578
Manufacturer Phone6086438530
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMUELLER REVERSIBEL THUMB STABILIZER
Generic NameTHUMB STABILIZER
Product CodeILH
Date Received2016-01-06
Model Number62712
Catalog Number62712
Lot NumberNA
OperatorLAY USER/PATIENT
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMUELLER SPORTS MEDICINE, INC.
Manufacturer AddressPRAIRIE DU SAC WI US


Patients

Patient NumberTreatmentOutcomeDate
10 2016-01-06

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