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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAND BIOMECHANICS LAB, INC TURNKEY FCS
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HAND BIOMECHANICS LAB, INC TURNKEY FCS Back to Search Results
Model Number FCS-400
Device Problems Contamination (1120); Patient Device Interaction Problem (4001)
Patient Problem Bacterial Infection (1735)
Event Date 09/11/2015
Event Type  Injury  
Manufacturer Narrative
Determined device event from 1 of 9 possible device lots.Reviewed sterilization and sterilie barrier inspection records for all 9 lots.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included warning and cautions regarding pin site care.
 
Event Description
Physician reported a patient once had a pin site 'infection from side to side movement of the transverse pin through the bone'.
 
Event Description
Physicain reported a patient once had a pin site 'infection from side to side movement of the transverse pin through the bone'.
 
Manufacturer Narrative
Determined device event from 1 of 9 possible device lots.Reviewed sterilization and sterilie barrier inspection records for all 9 lots.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included warning and cautions regarding pin site care.
 
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Brand Name
TURNKEY FCS
Type of Device
TURNKEY FCS
Manufacturer (Section D)
HAND BIOMECHANICS LAB, INC
77 scripps drive, suite 104
sacramento CA 95825
MDR Report Key7113183
MDR Text Key94699644
Report Number2919128-2017-00003
Device Sequence Number1
Product Code JEC
Combination Product (y/n)N
PMA/PMN Number
K072432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberFCS-400
Device Catalogue NumberFCS-400
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/11/2015
Initial Date FDA Received12/13/2017
Supplement Dates Manufacturer Received09/11/2015
Supplement Dates FDA Received12/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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