MAUDE Adverse Event Report: ASO LLC. ANTIBACTERIAL WATERPROOF ADHESIVE PAD; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Caustic/Chemical Burns (2549); Skin Burning Sensation (4540)

Event Date 01/28/2023

Event Type  Injury  

Event Description

Used a rexall antibacterial waterproof adhesive pad on my shoulder to cover an infected cyst.Took the pad off at the end of the day and the tape part of the bandage burned my skin around the cyst.Today is (b)(6) 2023 and my skin is still burning where the adhesive part was.

• Brand Name: ANTIBACTERIAL WATERPROOF ADHESIVE PAD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ASO LLC.
• MDR Report Key: 16294995
• MDR Text Key: 308923998
• Report Number: MW5114664
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): Y
• 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: 02/01/2023

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White