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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. STRAP RPLT ACTIVE HEEL TRACTION BOOT APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 72203275
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference case: (b)(4).
 
Event Description
It was reported that active heel traction boot replacement kit was loosening and it was not maintaining tension on the boot causing the patient´s foot to slide, ultimately impacting distraction. This was noticed before the procedure; therefore, no patient was involved. A backup device was available and no delay was reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameSTRAP RPLT 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
MDR Report Key11273900
MDR Text Key233461740
Report Number3003604053-2021-00029
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72203275
Device Catalogue Number72203275
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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