MAUDE Adverse Event Report: Candela Corporation

Device Problem Device Operational Issue (2914)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  Malfunction  

• Manufacturer (Section G): Candela Corporation; 530 boston post road; wayland MA 01778
• Manufacturer Contact: yverre bobay ; 530 boston post road; wayland, MA 01778 ; 5083580304
• MDR Report Key: 10083477
• Report Number: COR20000122-000
• Device Sequence Number: 1
• Product Code: EWG

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/22/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/22/2020
• 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