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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSSUR REBOUND DIABETIC WALKER LARGE; JOINT, ANKLE, EXTERNAL BRACE
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OSSUR REBOUND DIABETIC WALKER LARGE; JOINT, ANKLE, EXTERNAL BRACE Back to Search Results
Model Number B-242500004
Device Problem Break (1069)
Patient Problem Ulcer (2274)
Event Date 09/10/2014
Event Type  Injury  
Event Description
Patient was fit with a large diabetic walker.Boot was fit 1 inch away from the longest toe.High arched foot with prominent metatarsal heads.Patient claims the strap rivet sheared through the boot liner causing a dime size ulcer on his foot.
 
Manufacturer Narrative
Failure is still under investigation, supplemental report will be provided upon completion of investigation.
 
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Brand Name
REBOUND DIABETIC WALKER LARGE
Type of Device
JOINT, ANKLE, EXTERNAL BRACE
Manufacturer (Section D)
OSSUR
foothill ranch CA
Manufacturer Contact
karen montes
27051 towne centre dr
foothill ranch, CA 92610
9493823741
MDR Report Key4209624
MDR Text Key5153691
Report Number2085446-2014-00004
Device Sequence Number1
Product Code ITW
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberB-242500004
Device Catalogue NumberB-242500004
Device Lot Number352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/26/2014
Initial Date FDA Received10/21/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2013
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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