MAUDE Adverse Event Report: ASO LLC DELHAIZE; PLASTIC ANTIBACTERIAL BANDAGE

Model Number UPC725439933001

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

As of 03/18/2016 aso has not received response to our requests for returned samples of the device and a lot number.Aso is unable to further investigate this complaint.However, aso has reviewed records of biocompatibility tests.Aso will follow-up with the consumer according to our procedures and follow-up on this report if there is any new information.No samples or lot number provided.

Event Description

Consumer reported that she had a reaction to the adhesive on the bandages.

Manufacturer Narrative

Aso received returned samples from consumer but no lot number was provided.Returned samples were tested for adhesion properties and results are acceptable with no defects found during testing.

Event Description

Consumer reported that she had a reaction to the adhesive on the bandages.

• Brand Name: DELHAIZE
• Type of Device: PLASTIC ANTIBACTERIAL BANDAGE
• 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: 5511284
• MDR Text Key: 40703546
• Report Number: 1038758-2016-00042
• 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,Followup
• Report Date: 02/19/2016

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: UPC725439933001
• Device Catalogue Number: 072543993300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1