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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Lumenis Ltd.

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Lumenis Ltd. Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem Radiation Exposure, Unintended (3164)
Event Type  Other  
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Manufacturer (Section G)
Lumenis Ltd.
6 hakidma street
po box 240
yokneam 20692
IS 20692
Manufacturer Contact
alan vaisman
6 hakidma street
po box 240
IS   20692
MDR Report Key7953907
Report NumberCOR18001629-000
Device Sequence Number1
Product Code EWG
Combination Product (Y/N)
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 10/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2018
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation?
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No Answer Provided
Type of Device Usage Invalid Data

Date Received: 10/10/2018 Patient Sequence Number: 1