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

Model Number UPC# 681131286251

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Rash (2033)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2023 manufacturer evaluated retained samples of the same lot reported 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.

Event Description

On the initial report received by aso on (b)(6) 2023, the consumer stated that the product ripped her skin and caused irritation, bleeding, and scars.The consumer states that she went to the doctor.

Manufacturer Narrative

As of 11/10/2023 manufacturer evaluated retained samples of the same lot reported 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.As of 12/01/2023 aso received the unused product from the consumer.Returned product samples were submitted to the lab with no defects noted.

Event Description

On the initial report received by aso on 10/20/2023, the consumer stated that the product ripped her skin and caused irritation, bleeding, and scars.The consumer states that she went to the doctor.The consumer returned customer information request (cir) on 11/21/2023.The consumer did not specify what type of treatment she had.

• Brand Name: EQUATE
• Type of Device: KINESIOLOGY TAPE
• 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.; 9413790300
• MDR Report Key: 18116253
• MDR Text Key: 327887583
• Report Number: 1038758-2023-00030
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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: 300132
• Device Lot Number: 00182522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female