MAUDE Adverse Event Report: ASO LLC WALGREENS BLISTER CARE LARGE ADHESIVE BANDAGES; TAPE AND BANDAGE, ADHESIVE

Lot Number 00096718

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Irritation (1941)

Event Type  Injury  

Event Description

I used (b)(6) adhesive bandages to treat a burn wound for 3 days.By the end of that time i had some slight irritation and discontinued use.Over the last week since i stopped use, the dermatitis has become progressively very severe and will not subside despite multiple attempts to treat.I have a wound now of skin injury in the precise shape of the bandage on my skin in addition to the original injury.Fda safety report id# (b)(4).

• Brand Name: WALGREENS BLISTER CARE LARGE ADHESIVE BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ASO LLC
• MDR Report Key: 8712110
• MDR Text Key: 148534047
• Report Number: MW5087440
• 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: 06/15/2019

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: No Information
• Device Expiration Date: 04/30/2021
• Device Lot Number: 00096718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 34 YR