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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESTORATIVE CARE OF AMERICA, INC. TA / WALKING BOOT COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT

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RESTORATIVE CARE OF AMERICA, INC. TA / WALKING BOOT COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT Back to Search Results
Model Number TA SERIES
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2016
Event Type  Malfunction  
Event Description

The two side screws - that the side supports vertically - fell out, the screws were reattached. The clinic reported this is not the first time this has happened with this boot, from this manufacturer, on other patients. Manufacturer response for walking boot, ta / walking boot (per site reporter): the clinic has informed the manufacturer more than once about this recurring problem. Unknown response. Clinic will no longer use this manufacturer as the problem is not being corrected.

 
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Brand NameTA / WALKING BOOT
Type of DeviceCOMPONENT, EXTERNAL, LIMB, ANKLE/FOOT
Manufacturer (Section D)
RESTORATIVE CARE OF AMERICA, INC.
12221 33rd street north
st. petersburg FL 33716
MDR Report Key5593436
MDR Text Key43178984
Report Number5593436
Device Sequence Number1
Product Code IQI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
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 Received04/21/2016
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberTA SERIES
Device Catalogue Number78TA SERIES
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2016
Event Location Hospital
Date Report TO Manufacturer04/05/2016
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/21/2016 Patient Sequence Number: 1
Treatment
NO
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