MAUDE Adverse Event Report: ASO LLC TARGET; SHEER ANTIBACTERIAL ADHESIVE BANDAGE 4.5OZ

Model Number UPC017276226195

Device Problem Failure to Obtain Sample (2533)

Patient Problem Skin Irritation (2076)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

Aso was unable to evaluate samples from the same lot number as consumer disposed of product and could not provide with a lot number.Aso has evaluated reports of biocompatibility tests performed on materials used to manufacture the same product.Aso has reviewed the complaint database for possible trending on adverse events on this type of product and found that the.Consumer disposed of device.

Event Description

Consumer used device and the adhesive on it stuck to her skin and caused a rash.

Manufacturer Narrative

Aso has reviewed the complaint database for possible trending on adverse events on sheer antibacterial product and found that the number of reportable adverse events for the year 2015 is equivalent to 1.41 cpmus.However, since no lot number information was provided, aso could not evaluate a trend on a lot number.

• Brand Name: TARGET
• Type of Device: SHEER ANTIBACTERIAL ADHESIVE BANDAGE 4.5OZ
• 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: 5371006
• MDR Text Key: 36112565
• Report Number: 1038758-2016-00005
• 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: 12/17/2015

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: No Information
• Device Model Number: UPC017276226195
• Device Catalogue Number: 11305055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: No
• 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