MAUDE Adverse Event Report: 3M COMPANY NEXCARE WATERPROOF TAPE; TAPE AND BANDAGE, ADHESIVE

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Erythema (1840); Itching Sensation (1943); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 11/14/2021

Event Type  Injury  

Event Description

I applied the nexcare waterproof tape to my neck as a method to secure gauze to cover my surgical incision.About a day or two later, i removed the tape due to experiencing severe burning and itching to the area the tape was applied.Upon removal of the tape, i observed swollen red patches.Fda safety report id # (b)(4).

• Brand Name: NEXCARE WATERPROOF TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 12851916
• MDR Text Key: 281139699
• Report Number: MW5105481
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/17/2021

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: 11/19/2021
• Patient Sequence Number: 1
• Treatment: OXYCODONE/APAP; RIZATRIPTAN ; TIZANIDINE
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American