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 Code	Rash (2033)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 12/01/2025 the manufacturer has completed their investigation with no issues found.The returned sample results were satisfactory within range of specification with no defects noted.Aso reviewed records of biocompatibility tests with no issues noted.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
On the initial report received on october 16, 2025, the consumer stated that the product caused her rash.On the completed consumer information report (cir) received on november 11, 2025, the consumer stated that she used the tape on her right shoulder and broke out in a rash.She had to use tacrolimus ointment 0.1%.It helped with the itching and helped to heal the rash.Consumer confirmed that the symptoms corrected after she stopped using the product.

• 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: 23756917
• Report Number: 1038758-2025-00033
• Device Sequence Number: 21358468
• Product Code: KGX
• UDI-Device Identifier: 00681131286251
• UDI-Public: 00681131286251
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 12/09/2025

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: 244858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• 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: Female