MAUDE Adverse Event Report: ASO LLC WALGREENS; SHEER ANTIBACTERIAL ADHESIVE PAD 2X3

Model Number UPC311917142272

Device Problem Failure to Obtain Sample (2533)

Patient Problems Pain (1994); Scar Tissue (2060); Swelling (2091)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

Aso was unable to perform testing of the device as this was disposed of by the store and there was no lot number provided.However, aso reviewed records of biocompatibility tests.Refer to this report for further details.No lot information or returned samples.

Event Description

Consumer reported a reaction to the adhesive on the bandage, her arm was swollen and red.She sought medical attention.Consumer reported scars after 13 days.

• Brand Name: WALGREENS
• Type of Device: SHEER ANTIBACTERIAL ADHESIVE PAD 2X3
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5464592
• MDR Text Key: 39194193
• Report Number: 1038758-2016-00028
• 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: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2016

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
• Device Model Number: UPC311917142272
• Device Catalogue Number: 139780
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1