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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MUELLER SPORTS MEDICINE, INC. FASCIADERM; PLANTAR FASCILITIS PAIN RELIEF SYSTEM
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MUELLER SPORTS MEDICINE, INC. FASCIADERM; PLANTAR FASCILITIS PAIN RELIEF SYSTEM Back to Search Results
Model Number 6337
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 02/04/2015
Event Type  Injury  
Manufacturer Narrative
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
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.
 
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Brand Name
FASCIADERM
Type of Device
PLANTAR FASCILITIS PAIN RELIEF SYSTEM
Manufacturer (Section D)
MUELLER SPORTS MEDICINE, INC.
prairie du sac WI
Manufacturer Contact
1 quench dr.
prairie du sac, WI 53578
6086438530
MDR Report Key5366370
MDR Text Key36027859
Report Number2110420-2015-00003
Device Sequence Number1
Product Code FQM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number6337
Device Catalogue Number6337
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 Number1
Patient Outcome(s) Required Intervention;
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