FDA Adverse Event Injury Summary report: N

SUPERPATCH FLOW, DEFEND, VICTORY, FREEDOM

MDR report key: 20532926 · Received October 24, 2024

Report

Report Number
MW5161565
Event Type
Injury
Date Received
October 24, 2024
Date of Event
January 3, 2024
Report Date
January 28, 2024
Manufacturer
THE SUPER PATCH COMPANY LTD LLC.
Product Code
HXT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2024 I PURCHASED SEVERAL HUNDRED DOLLARS OF SUPERPATCHES WHICH I RECEIVED JANUARY 10TH. ON JANUARY 16TH, I REQUESTED A FULL REFUND OF MY PURCHASE PRICE IN ACCORDANCE WITH THE SUPERPATCH 30-DAY GUARANTEE LISTED ON THE BILL OF PURCHASE AND ON THEIR WEBSITE. I PURCHASED THE PATCHES PRIMARILY FOR MY WIFE. SHE IS NOT OVERLY SENSITIVE, HOWEVER AFTER USING THE PATCH SHE EXPERIENCED A SEVERE SKIN REACTION INCLUDING REDNESS AND ITCHING WHICH PERSISTED OVER 2 WEEKS AFTER HER SEVERE REACTION TO THE PATCH. SHE WAS TREATED WITH CORTISONE CREAM, BUT STILL THE REDNESS AND ITCHING PERSISTS. HER DOCTOR ADVISED TO NOT RECHALLENGE WITH THE PATCH. I RETURNED ALMOST ALL THE PATCHES (SHE USED ONLY 2) YET THE COMPANY HAS NOT REFUNDED ANY MONEY AS OF (B)(6) 2024. BASED ON MY INFORMATION, THESE PATCHES ARE BEING SOLD AS A CURE FOR MANY AILMENTS BUT ARE JUST STICKERS. IT IS CLASSIC PSEUDO-SCIENCE. REF REPORT: MW5161566.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1001243 SUPERPATCH FLOW, DEFEND, VICTORY, FREEDOM TAPE, ORTHOPEDIC HXT THE SUPER PATCH COMPANY LTD LLC.

Patients

Seq Age Sex Outcome Treatment
1 57 YR Female Required Intervention