MAUDE Adverse Event Report: EQUATE / ASO LLC EQUATE STERILE BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 187744

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2021

Event Type  Injury  

Event Description

Daughter had an accident, went to bandage her foot with equate sterile bandages and noticed something was greatly amiss.Looked up the product, and it says it is an hvac duct adhesive tape; definitely not intended for wound closure.Fda safety report id # b)(4).

• Brand Name: EQUATE STERILE BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): EQUATE / ASO LLC
• MDR Report Key: 12173139
• MDR Text Key: 261914732
• Report Number: MW5102545
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187744
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 MO
• Patient Weight: 14