MAUDE Adverse Event Report: CANDELA CORPORATION CO2RE INTIMA; POWERED LASER SURGICAL / INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 10/18/2018

Event Type  Injury  

Event Description

My ob/gyn convinced me that the use of a laser to address vaginal atrophy would alleviate my pain.She said it was safe, painless, and effective.It was not any of those things and made the situation much worse.Fda safety report id# (b)(4).

• Brand Name: CO2RE INTIMA
• Type of Device: POWERED LASER SURGICAL / INSTRUMENT
• Manufacturer (Section D): CANDELA CORPORATION
• MDR Report Key: 9750690
• MDR Text Key: 181331109
• Report Number: MW5093252
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 54