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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMOBILIZER

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IMMOBILIZER Back to Search Results
Catalog Number 7704
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Arthritis (1723); Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544)
Event Date 08/09/1996
Event Type  Death  
Event Description

After i got the leg data: ko, immobilizer off, i would get something catching in knee when i bend down, later it started to do more when walking. Just got away from the table to get up, felt my knee turn when getting up to stand, that was with the wrap. After it was time to take off wrap, next day it did it again, with me walking, stop, step down on stair and sidewalk, in front of post office and back up on stair into truck/caravan to go home, the next day same thing happen. Leg ache at night in bed. Sidewalk even it showed. Arthritis leg, leg pain, stiff ankle. (b)(4).

 
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Brand NameIMMOBILIZER
Type of DeviceIMMOBILIZER
MDR Report Key5580882
MDR Text Key42871873
Report NumberMW5061710
Device Sequence Number1
Product Code IQI
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number7704
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/13/2016 Patient Sequence Number: 1
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