FDA Adverse Event Injury Summary report: N

COOLSCULPTING

MDR report key: 15067183 · Received July 19, 2022

Report

Report Number
MW5110985
Event Type
Injury
Date Received
July 19, 2022
Date of Event
September 21, 2021
Report Date
July 16, 2022
Manufacturer
ALLERGAN/ABBVIE IRELAND NL B.V. BALLYTIVNAN
Product Code
OOK
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD COOLSCULPTING DONE ON MY UPPER AND LOWER ABDOMEN. IT LOOKED PRETTY GOOD FOR 3-4 MONTHS AND THEN LITERALLY OVERNIGHT I WOKE UP AND MY STOMACH HAD TRIPLED IN SIZE. LARGE FAT DEPOSITS IN THE SHAPE OF THE COOLSCULPTING APPLICATOR APPEARED EXACTLY WHERE THEY HAD BEEN PLACED. THE FAT IS DENSE, RUBBERY FIBROUS AND VERY LARGE. TO HAVE THIS HAPPEN TO ME HAS BEEN NOTHING SHORT OF TRAUMATIZING. MY STOMACH IS COMPLETELY DISFIGURED. IT'S AFFECTED MY MENTAL HEALTH AND IS DESTROYING MY SELF ESTEEM. I HAVE SEEN 2 PLASTIC SURGEONS THEY BOTH HAVE THE SAME APPROACH. TO BEGIN WITH, I REQUIRE ONE LIPOSUCTION TREATMENT TO EACH AREA. WE WILL WATCH MY RECOVERY TO SEE HOW THAT GOES. I HAVE BEEN TOLD THAT I COULD POTENTIALLY REQUIRE A SECOND LIPOSUCTION SURGERY TO TREAT MY ISSUE. I'M ADDITION TO THIS, ONCE I HEAL FROM ABOVE SURGERIES, I WILL NEED A 3RD SURGERY WHICH IS A FULL TUMMY TUCK ABDOMINOPLASTY. THIS SURGERY WILL REQUIRE ONE MONTH OFF WORK AND I'M SELF EMPLOYED THEREFORE NO INCOME FOR A MONTH. THE TUMMY TUCK IS A VERY DIFFICULT RECOVERY. I WILL END UP WITH A SCAR FROM HIP TO HIP FOR THE REST OF MY LIFE. THE TOTAL COST FOR SURGERIES IS (B)(6) AND I'VE BEEN OFFERED (B)(6) IN COMPENSATION FROM THE COMPANY THAT OWNS COOLSCULPTING. THIS HAS DESTROYED MY BODY, MY SELF ESTEEM AND MY FINANCES. THEY SAY IT'S A RARE SIDE EFFECT BUT I BELIEVE IT'S UNDER REPORTED BECAUSE HAVE THE "SHAME" ATTACHED TO THIS PROBLEM. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
252337 COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN/ABBVIE IRELAND NL B.V. BALLYTIVNAN

Patients

Seq Age Sex Outcome Treatment
1 48 YR Female Other