MAUDE Adverse Event Report: ASO LLC. ANTIBACTERIAL PERFORMANCE VARIETY PACK REXALL; TAPE AND BANDAGE, ADHESIVE

Lot Number 221202

Patient Problems Unspecified Infection (1930); Burning Sensation (2146); Unspecified Tissue Injury (4559)

Event Date 08/12/2023

Event Type  Injury  

Event Description

The product burned my skin and also peeled my skin off when my wife tried to remove bandage.I saw medical attention due to the burning feeling medical.The issue was with the tape area and treatment was required.I had to use antibiotics (augmentin) due to severe infected area.In addition, symptoms did not correct after i stopped using the product.I had accidentally cut myself shaving.Used to stop bleeding.

• Brand Name: ANTIBACTERIAL PERFORMANCE VARIETY PACK REXALL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ASO LLC.
• MDR Report Key: 17565981
• MDR Text Key: 321523429
• Report Number: MW5144682
• 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: 08/14/2023

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
• Device Lot Number: 221202
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White