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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 Problems Device Slipped (1584); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during a hip scope, the velcro on the leather padding failed and the patient's foot would slip when traction was applied.No backup device was available which resulted in procedure cancellation.
 
Manufacturer Narrative
An evaluation was performed by smith & nephew and could confirm the customer complaint for the glue on the leather padding failed.A visual inspection was performed and showed the velcro pad is not sticking to the boot.Smith & nephew will continue to monitor the new change that has been implemented.This serial number was manufactured before the change.
 
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Brand Name
AHTB ACTIVE HEEL TRACTION BOOT
Type of Device
APPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7963633
MDR Text Key123805035
Report Number3003604053-2018-00161
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 foreign,health professional,o
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72202682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Date Manufacturer Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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