MAUDE Adverse Event Report: CANDELA CORPORATION PROFOUND RF; POWER LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Erythema (1840); Inflammation (1932); Reaction (2414)

Event Date 02/28/2019

Event Type  Injury  

Event Description

Had "litique of face and neck, liposuction of neck" done at (b)(6).The procedure uses a combination of radio frequency technology with derma stamping to correct loose skin.My face was inflamed and swollen twice the size of my normal but i was told that was expected.The skin was covered with aquaphor ointment and i went home after the procedure.I noticed the presence of white pin-head size raised bumps where derma stamp was done and notified my cosmetic dr, dr.(b)(6) on (b)(6) 2019, he suggest to apply otc hydrocortisone cream that was started.Next 10 days, redness and edema slowly decreased.(b)(6) condition did not improve, contacted the dr, he ordered triamcinolone 0.5% cream.On (b)(6) 2019, condition does not improve and started medrol 4mg dosepack on (b)(6) 2019.As of today, (b)(6) 2019 raised bumps on my neck are less raised but visible, left cheek new bumps started to appear the night of (b)(6) 2019.I have appt to see dr (b)(6) on monday, (b)(6) 2019.I believe my condition is allergic foreign body granulomas, but that is my educated "guess" from researching the condition.I am retired registered nurse ((b)(6)), i have researched topics of safety and adverse reaction to micro needling and all i see is that it is rare for adverse reaction.We need to protect ourselves from med-spa clinic where any mds can open the lucrative business with minimal training and experiences.Please make those adverse reactions reportable to fda so that consumers can able to see the risk.Thank you.To me, this is caused by possibly electric conductor jell injected deep into my skin by derma stamp device.Profound rf (candela) that my immune reaction to substance.Aquaphor ointment entered via newly created channel hole triggered my hyperactive immune reaction.I am not a dr but those are the info i read in process of finding cure for my condition.I think it was result of bad protocol.Thank you.

• Brand Name: PROFOUND RF
• Type of Device: POWER LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CANDELA CORPORATION
• MDR Report Key: 8478758
• MDR Text Key: 140881441
• Report Number: MW5085519
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): Y
• 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: 03/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Weight: 59