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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIXES 4 KIDS E-THOTIC; SPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE, PRODUCT CODE: NOC
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FIXES 4 KIDS E-THOTIC; SPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE, PRODUCT CODE: NOC Back to Search Results
Device Problem Difficult to Open or Close (2921)
Patient Problem Pressure Sores (2326)
Event Date 01/01/2015
Event Type  Injury  
Event Description
Customer is complaining that they are following the manufacturer's recommendations on adjusting the tension of the e-thotic; however, based upon their last two patients they are finding the device is difficult to adjust and are having to remove the brace earlier than required.As such, the key surgeon for this device has stated, "i am holding off on further use for now".Additionally, the customer is returning all unused e-thotics, pin guides, pin guide holder and fixture (101,103, 201,202, & 203).The surgeon is stating, "my last two patients ended up in the er with swelling that required removing the e-thotic early.".
 
Manufacturer Narrative
Initial report was filed in error.Device is not imported.
 
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Brand Name
E-THOTIC
Type of Device
SPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE, PRODUCT CODE: NOC
Manufacturer (Section D)
FIXES 4 KIDS
2200 15th st n
wahpeton ND 58075
Manufacturer (Section G)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern ave.
union city CA 94587 1234
Manufacturer Contact
anne leblanc
30031 ahern av
union city, CA 94587-1234
5104291500
MDR Report Key4664173
MDR Text Key20019698
Report Number2921578-2015-00008
Device Sequence Number1
Product Code NOC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown,unknown,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/17/2015,03/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Is the Reporter a Health Professional? No
Distributor Facility Aware Date05/30/2014
Event Location Hospital
Date Report to Manufacturer03/17/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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