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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.
 
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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
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8491945
MDR Text Key141334277
Report Number3003604053-2019-00043
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/12/2019
1 Device was Involved in the Event
0 Patients were 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
Device Catalogue Number72202682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2019
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 Unkown

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