FDA Adverse Event Injury Summary report: N

TAPE, ORTHOPEDIC

MDR report key: 23830601 · Received December 17, 2025

Report

Report Number
MW5180722
Event Type
Injury
Date Received
December 17, 2025
Date of Event
December 11, 2025
Report Date
December 11, 2025
Manufacturer
THE SUPER PATCH COMPANY LTD LLC
Product Code
HXT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

STUDENT ARRIVED IN THE NURSE'S OFFICE EXTREMELY ITCHY ALL OVER HIS BODY. HE WAS ESPECIALLY SCRATCHING AT HIS UPPER BACK AND ARMS. WHEN I TOOK A LOOK, I SAW ABOUT 6 UNIDENTIFIABLE PATCHES. I CALLED DAD; HE SAID HE GIVES HIM "SUPER PATCH COMPANY" PATCHES TO HELP WITH "FOCUS". WHEN I ASKED HOW COME THERE ARE 6 PATCHES ON HIS BODY, HE SAID WELL ONE DOES FOCUS, OTHER DOES SLEEP AND SO ON. THEY ARE MEANT TO BE USED FOR DIFFERENT THING. I EXPLAINED TO HIM HOW HE'S SCRATCHING ALL OVER HIS BODY AND IS EXTREMELY UNCOMFORTABLE. STUDENT COULD NOT SIT STILL. I WAS ABLE TO GET THE PATCHES OFF WHERE I SAW SOME IRRITATION FROM THE ADHESIVE. THE COMPANY CLAIMS IT'S DRUG FREE BUT DOESN'T STATE HOW MANY PATCHES SHOULD BE ON THE BODY AT ONCE. IT ALSO STATES IT USES VIBROTACTILE STIMULATION WHICH CAN BE A CONTRIBUTING FACTOR TO THE EXTREME ITCHING. THERE IS NO AGE MINIMUM ON THE PRODUCT AS WELL. PT CODES: 1907, 1943. DEVICE CODE: 4001. REF REPORTS: MW5180718, MW5180719, MW5180720, MW5180721, MW5180723.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2039667 TAPE, ORTHOPEDIC TAPE, ORTHOPEDIC HXT THE SUPER PATCH COMPANY LTD LLC

Patients

Seq Age Sex Outcome Treatment
1 9 YR Male Other