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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDINOL ELUNIR 3.0X17 US CORONARY DRUG-ELUTING STENT

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MEDINOL ELUNIR 3.0X17 US CORONARY DRUG-ELUTING STENT Back to Search Results
Catalog Number LUN300R17US
Device Problems Stent; Appropriate Term/Code Not Available
Event Date 11/08/2019
Event Type  Injury  
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Brand NameELUNIR 3.0X17 US
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDINOL
8th hartom st. beck-tech bldg.
jerusalem 97775 08
IS  9777508
MDR Report Key9439462
Report Number1016427-2019-03636
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 12/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLUN300R17US
Device LOT NumberLNRUS00275
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/13/2019
Event Location Hospital
Date Report TO Manufacturer12/09/2019
Date Manufacturer Received11/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/09/2019 Patient Sequence Number: 1
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