MAUDE Adverse Event Report: WALGREENS/WALGREENS BOOTS ALLIANCE ASIA SOURCING LIMITED WALGREEN FLEXIBLE FABRIC XL BANDAGES; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Caustic/Chemical Burns (2549)

Event Date 09/16/2021

Event Type  Injury  

Event Description

Caller stated that she placed a (b)(6) flexible fabric xl bandages on a wound, the next day the skin under the bandage is severely burned which is still hurting and in a lot of pain.

• Brand Name: WALGREEN FLEXIBLE FABRIC XL BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WALGREENS/WALGREENS BOOTS ALLIANCE ASIA SOURCING LIMITED
• MDR Report Key: 12532743
• MDR Text Key: 273648799
• Report Number: MW5104216
• Device Sequence Number: 1
• Product Code: KGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/24/2021

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 81