MAUDE Adverse Event Report: ASO LLC CVS HEALTH; LARGE SHEER ADHESIVE PADS

Model Number UPC#050428358207

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

Patient Problem Skin Irritation (2076)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

As of 03/27/2018 aso was unable to perform additional testing, as no information of lot number and unused samples were provided.However, aso has verified records of biocompatibility testing.

Event Description

Consumer stated that after using the product for two days, it turned bright red on his stomach.

• Brand Name: CVS HEALTH
• Type of Device: LARGE SHEER ADHESIVE PADS
• 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
• MDR Report Key: 7379230
• MDR Text Key: 103743717
• Report Number: 1038758-2018-00009
• 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: 02/28/2018

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: UPC#050428358207
• Device Catalogue Number: 212837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/28/2018
• 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