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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAND BIOMECHANICS LAB, INC. DIGIT WIDGET
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HAND BIOMECHANICS LAB, INC. DIGIT WIDGET Back to Search Results
Model Number DWD-232
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problem Bacterial Infection (1735)
Event Date 06/06/2016
Event Type  Injury  
Manufacturer Narrative
Reviewed sterilization and sterile barrier inspection records of lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included caution regarding pin site care.
 
Event Description
It is reported that patient had surgery to install a digit widget to straighten a flexion contracture.Patient reported physician prescribed an antibiotic 61 days post operative for red and itchy pin sites.
 
Manufacturer Narrative
Reviewed sterilization and sterile barrier inspection records of lot.No pattern related to irradation dose lot or device lot was noted.Confirmed labeling included caution regardign pin site care.
 
Event Description
It is reported that patient had surgery to install a digit widget to straighten a flexion contracture.Patient reported physician prescribed an antibiotic 61 days post operative for red and itchy pin sites.
 
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Brand Name
DIGIT WIDGET
Type of Device
DIGIT WIDGET
Manufacturer (Section D)
HAND BIOMECHANICS LAB, INC.
77 scripps drive, suite 104
sacramento CA 95825
MDR Report Key7113191
MDR Text Key94726479
Report Number2919128-2017-00004
Device Sequence Number1
Product Code JDW
Combination Product (y/n)N
PMA/PMN Number
K992970
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
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 NumberDWD-232
Device Catalogue NumberDWD-232
Device Lot NumberDWD-115-113A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/14/2016
Initial Date FDA Received12/13/2017
Supplement Dates Manufacturer Received06/14/2016
Supplement Dates FDA Received12/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
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