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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW SCREW,FIXATION,BONE

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MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW SCREW,FIXATION,BONE Back to Search Results
Catalog Number 186715000
Device Problem Unintended Movement
Event Date 01/01/2019
Event Type  Injury  
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Brand NameMIS SINGLE INNER SETSCW
Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle MA 02400
SZ  02400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle , MA 02400
  02400
6103142063
MDR Report Key9580964
Report Number1526439-2020-00359
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number186715000
Device LOT Number245498
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/12/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/13/2020 Patient Sequence Number: 1
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