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

Model Number UPC#681131286244

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

Patient Problems Rash (2033); Skin Tears (2516)

Event Date 09/25/2023

Event Type  Injury  

Event Description

On the initial report received by aso on (b)(6)2023, the consumer stated that the product stuck to her skin, caused a rash, and tore her skin.The consumer went to the dr., and the nurse was able to remove the product, but she still had the rash.

Manufacturer Narrative

As of (b)(6)2023 manufacturer evaluated retained samples of the same lot reported with no defects noted.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.

• 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: 17979954
• MDR Text Key: 326236583
• Report Number: 1038758-2023-00028
• 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
• Report Date: 10/20/2023

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#681131286244
• Device Catalogue Number: 578868774
• Device Lot Number: 00183413
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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