FDA Adverse Event Injury Summary report: N

PLAMERE PLASMA PEN

MDR report key: 13548992 · Received February 16, 2022

Report

Report Number
MW5107528
Event Type
Injury
Date Received
February 16, 2022
Date of Event
January 7, 2022
Report Date
February 14, 2022
Manufacturer
GCS CO., LTD
Product Code
ISA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AR, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I NEED CORRECTIVE PROCEDURES; MY ESTHETICIAN RECENTLY TALKED ME INTO A NEW PROCEDURE SHE WAS JUST CERTIFIED IN, CALLED PLASMA FIBROBLAST. SHE WANTED TO DO IT FOR FREE FOR ADVERTISING. I DID RESEARCH, AND REALLY COULDN'T FIND ANYTHING OTHER THAN A BUNCH OF COMPETITIVE ADVERTISING. I WENT AHEAD AND DID IT. FIRST OF ALL, IT WAS VERY PAINFUL, DESPITE THE NUMBING AGENT SHE USED. AFTERWARDS, SHE TOLD ME SHE HAD USED A MUCH HIGHER INTENSITY FOR "MORE LIFT." I FOLLOWED ALL HER AFTERCARE INSTRUCTIONS AND I AM STILL LEFT WITH DEEP SCARS. SHE HAS OFFERED TO "MAKE IT RIGHT" WITH EVEN MORE COSMETIC PROCEDURES. SHE WANTS TO DO 2 CHEMICAL PEELS AND THEN MICRONEEDLING TO TRY TO CORRECT IT. I WAS NEVER TOLD THIS COULD BE A POSSIBILITY. AFTER ALL THIS, I FOUND OUT THAT SHE GOT HER CERTIFICATION IN 48 HOURS ONLINE AND PRACTICED ON FRUIT!! THIS DEVICE THAT SHE IS USING-THE PLAMERE PLASMA PEN, HAS ALREADY BEEN BANNED IN (B)(6), AND I BELIEVE FOR GOOD REASON! THIS DEVICE NEEDS MORE TESTING AND SHOULD REQUIRE BETTER HANDS ON TRAINING. SHE'S COMPLETELY DELETED MY PROCEDURE FROM HER BUSINESS PAGE AND DID NOT SHOW THE UPDATES. SHE IS VERY BUSY, DOING THIS TO A GOOD AMOUNT OF WOMEN IN THE LAST 2 MONTHS! I'M SURE THERE ARE MORE TO COME. THIS DEVICE NEEDS BANNED! I AM LEFT WITH SCARS, AND ANXIETY. I'M AFRAID TO GET ANOTHER TREATMENT FROM HER AND CANNOT AFFORD TO GO TO SOMEONE ELSE FOR A SECOND OPINION. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
538496 PLAMERE PLASMA PEN MASSAGER, THERAPEUTIC, ELECTRIC ISA GCS CO., LTD

Patients

Seq Age Sex Outcome Treatment
1 36 YR Female Other