MAUDE Adverse Event Report: ASO LLC UP & UP; FABRIC BANDAGES

Model Number UPC#017276226249

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

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on 11/18/2019 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of 12/12/2019 no product was available for testing and no lot number was provided.Aso reviewed records of biocompatibility tests and latex screenings.Refer to section of this report for further details.

Event Description

On the initial report on 10/22/2019 consumer reported having an allergic reaction to the bandages.On cir received on 11/18/2019 consumer stated sought medical attention.

• Brand Name: UP & UP
• Type of Device: FABRIC 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: 9461494
• MDR Text Key: 184891381
• Report Number: 1038758-2019-00057
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#017276226249
• Device Catalogue Number: 245070700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• 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