MAUDE Adverse Event Report: ASO LLC NO BRAND PROVIDED BY CONSUMER; ANTIBACTERIAL DECORATED BANDAGE

Model Number UPC017276229882

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

Aso has been unable to received further information from consumer.As of (b)(6) 2016 aso has attempted to contact the consumer in three different occasions with no response.Aso will follow-up on this report if any additional information is provided by the consumer.

Event Description

Consumer reported that the bandage ripped her skin right off.

• Brand Name: NO BRAND PROVIDED BY CONSUMER
• Type of Device: ANTIBACTERIAL DECORATED 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: 5551180
• MDR Text Key: 41989061
• Report Number: 1038758-2016-00049
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2016

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: UPC017276229882
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 04/06/2016
• 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