MAUDE Adverse Event Report: WAL-MART STORES, INC. EQUATE FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL JUMBO; TAPE AND BANDAGE, ADHESIVE

Lot Number 210601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Burning Sensation (2146); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 01/21/2022

Event Type  Injury  

Event Description

I used an equate antibacterial bandage to cover an opened packed wound and within 2 hours my skin was burning.I took the bandage off and the area is still burning.It is red, inflamed and has blisters.It is causing very bad irritation and is very painful.Non testing was done.I will not go to the hospital over this.Fda safety report id# (b)(4).

• Brand Name: EQUATE FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL JUMBO
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WAL-MART STORES, INC.; 702 sw 8th st.; bentonville AR 72716
• MDR Report Key: 13424132
• MDR Text Key: 285014897
• Report Number: MW5107118
• 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: 01/21/2022

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
• Device Lot Number: 210601
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Patient Sequence Number: 1
• Treatment: ALBUTEROL ; ALLEGRA; SPIRONOLACTONE; TYLENOL
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 150 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White