MAUDE Adverse Event Report: CVS PHARMACY, INC. CVS HEALTH KINESIOLOGY ATHLETIC TAPE STRIPS; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blister (4537); Localized Skin Lesion (4542)

Event Date 07/28/2022

Event Type  Injury  

Event Description

Tape caused blisters and layer of skin to peel off when removed.My daughter now has tape shaped scabs where tape was used.Fda safety report id# (b)(4).

• Brand Name: CVS HEALTH KINESIOLOGY ATHLETIC TAPE STRIPS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CVS PHARMACY, INC.; one cvs dr.; woodsocket RI 02895
• MDR Report Key: 15193434
• MDR Text Key: 297686211
• Report Number: MW5111381
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/06/2022

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2022
• Patient Sequence Number: 1
• Treatment: ADVIL; ALEVE; BENADRYL (ALL AS NEEDED); CLARITIN ; MELATONIN ; TYLENOL
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White