MAUDE Adverse Event Report: CANDELA CORPORATION VBEAM- CANDELA PERFECTA; POWERED LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hot Flashes/Flushes (2153); Swelling/ Edema (4577)

Event Date 10/21/2022

Event Type  Injury  

Event Description

Vbeam treatment- severe flushing, intense redness, swelling when i flush or go out to hot places/out in sun, and i'm not talking about slight swelling.Complete heat intolerance.Tons of broken capillaries all over my face.This laser has ruined my life.

• Brand Name: VBEAM- CANDELA PERFECTA
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CANDELA CORPORATION
• MDR Report Key: 15933079
• MDR Text Key: 305134508
• Report Number: MW5113675
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White