MAUDE Adverse Event Report: ASO LLC DOLLAR GENERAL; FABRIC ANTIBACTERIAL BANDAGES

Model Number UPC017276228168

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 03/12/2016

Event Type  Injury  

Manufacturer Narrative

As of 4/11/2016 aso has not received returned samples from consumer or a lot number in order to test retained samples of the same lot number.Aso has reviewed records for biocompatibility data.Refer to section of this report for further details.

Event Description

Consumer reported that she was using the bandages on a sore she had on her arm.When she removed the bandage, it took her skin off with it.

• Brand Name: DOLLAR GENERAL
• Type of Device: FABRIC ANTIBACTERIAL BANDAGES
• 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: 5568260
• MDR Text Key: 42372714
• Report Number: 1038758-2016-00051
• 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: 03/12/2016

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: UPC017276228168
• Device Catalogue Number: 00462501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2016
• Initial Date FDA Received: 04/11/2016
• 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