MAUDE Adverse Event Report: KT HEALTH, LLC. KT TAPE PRO; BANDAGE, ELASTIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 02/07/2020

Event Type  Injury  

Event Description

Blisters.Wore kt tape x 3 hours on thurs (b)(6) 2020.Removed and showed after practice.The next day the area had extensive blistering.Did the problem stop after the person reduced the dose or stopped taking or using the product? yes.Quantity: 2 strips.Frequency: daily.How was it taken or used: topical.Date the person started taking or using the product: (b)(6) 2020.Date the person stopped taking or using the product: (b)(6) 2020.

• Brand Name: KT TAPE PRO
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): KT HEALTH, LLC.
• MDR Report Key: 9706262
• MDR Text Key: 179448165
• Report Number: MW5092962
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Weight: 74