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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CALF STRAP EQUIPMENT RPLT AHTB APPARATUS, TRACTION, NON-POWERED

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SMITH & NEPHEW, INC. CALF STRAP EQUIPMENT RPLT AHTB APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 72204017
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2021
Event Type  malfunction  
Manufacturer Narrative
(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 NameCALF STRAP EQUIPMENT RPLT AHTB
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 Key11273952
MDR Text Key230112474
Report Number3003604053-2021-00031
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 03/17/2021
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 Number72204017
Device Catalogue Number72204017
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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