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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. TENDERFOOT HEEL INCISION DEVICE
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INTERNATIONAL TECHNIDYNE CORP. TENDERFOOT HEEL INCISION DEVICE Back to Search Results
Model Number TF1000I
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2013
Event Type  malfunction  
Event Description
Healthcare professional reported that the tenderfoot device came apart prior to use and was not used.No adverse event reported.
 
Manufacturer Narrative
This mdr submitted 10/28/2014 refers to itc complaint case (b)(4).Retrospective analysis of complaint records where the tenderfoot identified this case for reportability.No ncmrs were identified for the device.No related complaint trends identified.
 
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Brand Name
TENDERFOOT HEEL INCISION DEVICE
Manufacturer (Section D)
INTERNATIONAL TECHNIDYNE CORP.
edison NJ 08820
Manufacturer Contact
eleanor fox
23 nevsky st.
edison, NJ 08820
7325485700
MDR Report Key4239929
MDR Text Key21081996
Report Number2250033-2014-00007
Device Sequence Number1
Product Code JCA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K883968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/17/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2017
Device Model NumberTF1000I
Device Catalogue NumberTF1000I
Device Lot NumberBH336M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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