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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 Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/1901
Event Type  malfunction  
Event Description
It was reported that, during a hip arthroscopy, the active heel traction boot failed in a way that caused loss of patient positioning. A back-up device was used to complete the procedure. The surgery was not delayed. The patient was not harmed. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9356531
MDR Text Key179441100
Report Number3003604053-2019-00131
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2019
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 Manufacturer01/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2020
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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