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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Candela Corporation

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Candela Corporation Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem Radiation Exposure, Unintended (3164)
Event Type  Malfunction  
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Manufacturer (Section G)
Candela Corporation
530 boston post road
wayland MA 01778
Manufacturer Contact
yverre bobay
530 boston post road
wayland, MA 01778
MDR Report Key8707292
Report NumberCOR19000288-000
Device Sequence Number1
Product Code EWG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 06/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2019
Is This A Product Problem Report? Yes
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