FDA Adverse Event Injury Summary report: N

KT TAPE PRO

MDR report key: 23148673 · Received September 25, 2025

Report

Report Number
3007282994-2025-00002
Event Type
Injury
Date Received
September 25, 2025
Date of Event
August 23, 2025
Report Date
September 19, 2025
Manufacturer
KT HEALTH, LLC
Product Code
FQM
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

ON 26-AUG-2025, THIS SPONTANEOUS REPORT WAS RECEIVED REGARDING A 79-YEAR-OLD FEMALE IN ASSOCIATION WITH PRO 20 STRIP 10 INCHES PRECUT STEALTH BEIGE TAPE. ON (B)(6) 2025, THE CONSUMER'S SURGICAL BANDAGE WAS PEELING UP AND SHE TAPED THE HOSPITAL BANDAGE DOWN AT THE TOP AND SIDES WITH THE PRO 20 STRIP 10 INCHES PRECUT STEALTH BEIGE TAPE. ON (B)(6) 2025, THE CONSUMER NOTED SWELLING TO THE AREA. SHE ELEVATED IT AND ICED IT BECAUSE SHE THOUGHT IT WAS FROM THE SURGERY. ON (B)(6) 2025, SHE NOTICED REDNESS. ON (B)(6) 2025, SHE WENT TO THE EMERGENCY ROOM (ER). SHE WAS ADMITTED TO THE HOSPITAL AND STAYED ONE NIGHT. THE DOCTORS DETERMINED THAT HER REACTION MIGHT HAVE BEEN FROM SOMETHING TOPICAL USED. THERE WAS NO REDNESS UNDER THE SURGICAL BANDAGE AND ONLY REDNESS UNDERNEATH THE TAPE. SHE APPLIED BENADRYL CREAM WHICH HAD BEEN HELPING. AN ULTRASOUND, CHEST CT WITH INTRAVENOUS CONTRAST, AND X-RAY OF THE KNEE HAD NORMAL RESULTS. SHE WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS AND SENT HOME WITH CEPHALEXIN TO CONTINUE. SHE WAS SCHEDULED FOR PHYSICAL THERAPY AND ANTICIPATED A FOLLOW UP WITH HER SURGEON AT THE END OF (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2766287 KT TAPE PRO KINESIOLOGY TAPE FQM KT HEALTH, LLC

Patients

Seq Age Sex Outcome Treatment
1 79 YR Female Required Intervention UNSPECIFIED BLOOD PRESSURE MEDICATION| UNSPECIFIED INHALERS