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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 Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during the procedure, the glue on the boot where the velcro was placed has come loose from the boot and the inner boot is moving while the patient¿s foot is inside.They said that once almost the patient¿s foot fell off during the surgery but there were no injuries.The procedure was finished with the same device with no delays.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer compliant for the velcro detached.A visual inspection was performed and showed the velcro pad is detached from the boot.The root cause is determined to be an adhesive failure.The loctite appears to have been applied as per work instructions, however it did not hold.Complaints will continue to be monitored for recurrence.
 
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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 Key8491945
MDR Text Key141334277
Report Number3003604053-2019-00043
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 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
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 Manufacturer04/16/2019
Date Manufacturer Received07/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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