MAUDE Adverse Event Report: ASO LLC EQUATE; ADHESIVE BANDAGE

Model Number 017276227802

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

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

(b)(6) 2015 - per customer: used one on (b)(6) daughter and next morning she had a severe reaction to the bandage.Picture submitted showed redness.

Manufacturer Narrative

The rate of complaints for the antibacterial line was evaluated with no increase noted since aso began to transition to antibacterial with additional skus.(b)(4).

• Brand Name: EQUATE
• Type of Device: ADHESIVE BANDAGE
• Manufacturer (Section D): ASO LLC; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 4687052
• MDR Text Key: 5675101
• Report Number: 1038758-2015-00010
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Type of Report: Initial
• Report Date: 04/09/2015

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: Lay User/Patient
• Device Model Number: 017276227802
• Device Lot Number: 5067-2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR