MAUDE Adverse Event Report: ASO LLC. EQUATE BANDAGE; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Pain (1994); Skin Tears (2516)

Event Date 04/04/2023

Event Type  Injury  

Event Description

I wore the equate bandage for 2 hours and when i took it off, took the skin off the top of my hand.It will take 2-3 months for the skin to grow back and will be a different color.Most painful thing ever.

• Brand Name: EQUATE BANDAGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ASO LLC.
• MDR Report Key: 16876922
• MDR Text Key: 314745519
• Report Number: MW5117267
• 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: 05/01/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female