MAUDE Adverse Event Report: CVS PHARMACY, INC. CVS HEALTH SENSITIVE SKIN GENTLE PAPER TAPE; TAPE AND BANDAGE, ADHESIVE

Catalog Number 830963

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Pain (1994); Skin Burning Sensation (4540)

Event Date 10/21/2022

Event Type  Injury  

Event Description

Reporter calling to report problems after using "cvs health sensitive skin paper tape for gentle removal on all skin types." she states she started using the paper tape and experienced pain, and an intense burning sensation.She initially thought this was just part of the normal recovery process as she had recently had a surgical incision, but upon removing the tape her skin was "red and bumpy" in the exact shape and size of the applied tape.She stopped using the tape but the burning sensation continued for "a few weeks" after that.She used an ice pack for pain control and to help her be able to fall asleep.

• Brand Name: CVS HEALTH SENSITIVE SKIN GENTLE PAPER TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CVS PHARMACY, INC.; 1 cvs dr.; woonsocket RI 02895
• MDR Report Key: 15834569
• MDR Text Key: 304120890
• Report Number: MW5113400
• 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
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 830963
• Device Lot Number: 22A001
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: ICE PACK
• Patient Age: 68 YR
• Patient Sex: Female