MAUDE Adverse Event Report: ASO LLC DOLLAR GENERAL; PLASTIC BANDAGE 3/4

Model Number UPC017276229059

Device Problem Failure to Obtain Sample (2533)

Patient Problems Abrasion (1689); Skin Irritation (2076)

Event Date 02/28/2016

Event Type  Injury  

Manufacturer Narrative

As of 03/28/2016 aso has not received returned samples of the product or a lot number in order to evaluate retained samples with the same lot number.Aso verified records of biocompatibility test data for materials used on the same type of products.Aso will continue to monitor the complaint database for possible trends.

Event Description

Consumer reported that the bandage caused an allergic reaction where the tape touched the skin and it took off a layer of skin.

• Brand Name: DOLLAR GENERAL
• Type of Device: PLASTIC BANDAGE 3/4
• 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: 5529447
• MDR Text Key: 41268146
• Report Number: 1038758-2016-00045
• 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: 02/28/2016

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: UPC017276229059
• Device Catalogue Number: 00460306
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2016
• Initial Date FDA Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1