MAUDE Adverse Event Report: SUZHOU MEDSPORTS PRODUCTS CO. LTD. EQUATE; KINESIOLOGY TAPE BLACK

Model Number	UPC# 681131286251
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 07/09/2025 manufacturer evaluated retained samples of the same lot reported with no defects noted.In addition, aso reviewed records of biocompatibility tests.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on device label.
Event or Problem Description
In the initial report received on (b)(6) 2025, the consumer stated that he and his spouse wore the tape all day at disneyland.After removing the tape in the shower, the spouse experienced irritation and a burning sensation.The consumer, who reported the event, also noted dryness and discoloration in the area where the adhesive tape had been applied.Consumer reported that medical attention was sought.The doctor said that it may have been a reaction due to sun exposure and it looked like a burn.
Additional Manufacturer Narrative
As of 07/30/2025 unused returned product was submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests with no issues noted.Refer to section b.6 of this report for further details.The following sections were updated: b5, b6, g2, g6, g6, and h6.Udi notes: the expiry date is not present on device label.
Event or Problem Description
In the initial report received on 06/11/2025, the consumer stated that he and his spouse wore the tape all day at (b)(6).After removing the tape in the shower, the spouse experienced irritation and a burning sensation.The consumer, who reported the event, also noted dryness and discoloration in the area where the adhesive tape had been applied.Consumer reported that medical attention was sought.The doctor said that it may have been a reaction due to sun exposure and it looked like a burn.In the completed consumer information report (cir) received on july 18, 2025, the consumer reported visiting a walk-in clinic, where a doctor prescribed a three-day course of steroids.Consumer reported that the symptoms did not correct after he stopped using the product.Consumer stated that the area has improved, but tape mark where the product was applied remains visible.

• Brand Name: EQUATE
• Common Device Name: KINESIOLOGY TAPE BLACK
• Manufacturer (Section D): SUZHOU MEDSPORTS PRODUCTS CO. LTD.; 128 fangzhou road suzhou ind.; loufeng east district, suzhou 21512 3 CN; CH 215123 CN
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 22457735
• Report Number: 1038758-2025-00015
• Device Sequence Number: 8597580
• Product Code: KGX
• UDI-Device Identifier: 00681131286251
• UDI-Public: 00681131286251
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC# 681131286251
• Device Catalogue Number: 578868775
• Device Lot Number: 234842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male