MAUDE Adverse Event Report: ASO LLC UP&UP; FLEXIBLE FABRIC EXTRA-LARGE BANDAGES

Model Number UPC#017276226256

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

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 05/03/2018

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 the product caused a chemical burn requiring medical attention.

• Brand Name: UP&UP
• Type of Device: FLEXIBLE FABRIC EXTRA-LARGE 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
• MDR Report Key: 7573793
• MDR Text Key: 110237928
• Report Number: 1038758-2018-00016
• 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: 05/07/2018

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#017276226256
• Device Catalogue Number: 245070727
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other