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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSSUR AMERICAS REBOUND AIR WALKER; JOINT, ANKLE, EXTERNAL BRACE

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OSSUR AMERICAS REBOUND AIR WALKER; JOINT, ANKLE, EXTERNAL BRACE Back to Search Results
Model Number B-242900003
Device Problem Break (1069)
Patient Problem Fall (1848)
Event Date 08/18/2015
Event Type  Injury  
Event Description
Patient using a rebound air walker walking boot claims the strap broke causing a fall.The pharmacy stated the patient claims they required a hospital visit, but is unable to verify.
 
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Brand Name
REBOUND AIR WALKER
Type of Device
JOINT, ANKLE, EXTERNAL BRACE
Manufacturer (Section D)
OSSUR AMERICAS
27051 towne centre
foothill ranch CA 92610
Manufacturer (Section G)
OSSUR AMERICAS
27051 towne centre
foothill ranch CA 92610
Manufacturer Contact
karen montes
27051 towne centre drive
foothill ranch, CA 92610
9493823741
MDR Report Key5243254
MDR Text Key31914162
Report Number2085446-2015-00002
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 Health Professional
Type of Report Initial
Report Date 11/20/2015
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? No
Device Operator Lay User/Patient
Device Model NumberB-242900003
Device Catalogue NumberB-242900003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/18/2015
Initial Date FDA Received11/23/2015
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) Other;
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