MAUDE Adverse Event Report: MUELLER SPORTS MEDICINE, INC. MUELLER BLUE KINESIOLOGY TAPE PRE-CUT STRIPS; SOLVENT, ADHESIVE TAPE

Lot Number FC6837-1_9.13

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 06/06/2019

Event Type  Injury  

Event Description

I used mueller blue kinesiology tape around my right knee and got a rash where the tape was.Fda safety report id# (b)(4).

• Brand Name: MUELLER BLUE KINESIOLOGY TAPE PRE-CUT STRIPS
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): MUELLER SPORTS MEDICINE, INC.
• MDR Report Key: 8700260
• MDR Text Key: 148216876
• Report Number: MW5087377
• Device Sequence Number: 1
• Product Code: KOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: FC6837-1_9.13
• 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): Disability
• Patient Age: 59 YR
• Patient Weight: 64