FDA Adverse Event Malfunction Summary report: N

12 CM EMBRACE DRESSING

MDR report key: 24758237 · Received April 1, 2026

Report

Report Number
MW5186276
Event Type
Malfunction
Date Received
April 1, 2026
Date of Event
March 25, 2026
Report Date
March 26, 2026
Manufacturer
NEODYNE BIOSCIENCES, INC.
Product Code
MDA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I STARTED USING THE EMBRACE SCAR TREATMENT PRODUCT FOR A BREAST LIFT. WHEN I ORDERED THE PRODUCT, I USED THEIR WEBSITE AND SELECTED BREAST LIFT AND THE APPROPRIATE INCISION TYPE. I ALSO READ THE IFU AND WATCHED THE YOUTUBE VIDEO. WHEN I OPENED THE PRODUCT, IT DID NOT CONTAIN THE PRODUCT USED IN THE VIDEO FOR THE VERTICAL INCISION AND OVER THE AREOLA. I CALLED CUSTOMER SERVICE ON 3/24/2026 AND THEY REVIEWED MY ORDER AND SAID IT WAS CORRECT AND RESENT THE LINK TO THE VIDEO EVEN THOUGH I INDICATED IT DID NOT MATCH THE PRODUCT THEY SENT ME. I WORE THE PRODUCT FOR TWO DAYS, IT WAS VERY UNCOMFORTABLE AND I BECAME CONCERNED THE PRODUCT USED ON THE VERTICAL INCISION AND AREOLA WAS NOT WIDE ENOUGH THEREFORE I HAD ADHESIVE ON PART OF THE SCAR. I CALLED CUSTOMER SERVICE AGAIN REQUESTING AN APPROPRIATE IFU AND VIDEO FOR A BREAST LIFT USING THE PRODUCT THEY RECOMMENDED AND WAS TOLD: "IT IS THE CONSUMERS RESPONSIBILITY TO MEASURE THEIR INCISIONS AND ORDER THE RIGHT SIZES." I TOLD HER THAT WAS NEVER ASKED FOR ON THE SITE THEY SIMPLY SEND A KIT FOR THE PROCEDURE YOU SELECT. I WENT BACK INTO THE SITE ON 3/26/2026 AND SEARCHED EVERYWHERE FOR A STEP-BY-STEP PROCESS TO MEASURE, SELECT AND ORDER PRODUCT IT WAS NOT THERE. THEY ARE FALSELY ADVERTISING THEY HAVE A PRODUCT FOR BREAST LIFT AND THAT THEY PROVIDE INSTRUCTIONS FOR USE. CUSTOMER SERVICE ALSO SAID IT WAS UP TO ME TO FIGURE OUT HOW TO USE THE PRODUCT BASED ON THE STANDARD IFU THAT IS FOR A FLAT INCISION NOT A BREAST LIFT. THEY ALSO HAVE A VIDEO FOR A BREAST LIFT THAT USES A DIFFERENT PRODUCT FOR THE VERTICAL INCISION AND AREOLA. I AM RETURNING THE PRODUCT. REFERENCED REPORTS: MW5186277, MW5186278.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
821803 12 CM EMBRACE DRESSING ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA NEODYNE BIOSCIENCES, INC. JU1178404

Patients

Seq Age Sex Outcome Treatment
1 64 YR Female