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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT APPARATUS, TRACTION, NON-POWERED

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SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 72202682
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2017
Event Type  malfunction  
Manufacturer Narrative
An evaluation was performed by smith & nephew and could not confirm the customer complaint for the device presented traction issues. A visual inspection was performed and showed no damage to the ahtb boot. All straps were attached properly and snapped together without issue. No manufacturing related defects were observed. This is considered as a no problem found. No further investigation is required.
 
Event Description
It was reported by customer that device presented traction issues.
 
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Brand NameAHTB ACTIVE HEEL TRACTION BOOT
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
james gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key6989558
MDR Text Key195673278
Report Number3003604053-2017-00318
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 12/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72202682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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