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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DONJOY; DEFIANCE DROPLOCK

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DJO, LLC DONJOY; DEFIANCE DROPLOCK Back to Search Results
Model Number CONV DEFIANCE DROPLOCK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fall (1848)
Event Date 01/29/2016
Event Type  Injury  
Manufacturer Narrative
Device not returned.
 
Event Description
Complaint received that alleges "hinge locked and made him fall, he fell in stairs when one brace locked while he was going down.He woke up in hospital because he lost consciousness after the fall.He stayed couple of days under observation and then he went back home".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.
 
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Brand Name
DONJOY
Type of Device
DEFIANCE DROPLOCK
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
Manufacturer (Section G)
DJO, LLC
3151 scott street
vista CA 92081 9663
Manufacturer Contact
william fisher
1430 decision street
vista, CA 92081
7607313126
MDR Report Key5730060
MDR Text Key47549735
Report Number2020737-2016-00007
Device Sequence Number1
Product Code ITQ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2016
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 Lay User/Patient
Device Model NumberCONV DEFIANCE DROPLOCK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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