MAUDE Adverse Event Report: ASO LLC WALGREENS; ANTIBACTERIAL PADS

Model Number UPC#311917142272

Device Problem Failure to Obtain Sample (2533)

Patient Problems Bruise/Contusion (1754); Rash (2033); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

As of 05/06/2020 unused samples or lot number were not provided.Aso has reviewed records of biocompatibility tests and latex screening with no issues noted.

Event Description

On the initial report of (b)(6) 2020 consumer stated that product caused an allergic reaction after applied in a cut on his chest.He added sought medical attention and was prescribed antibiotics due to the rash getting infected.

• Brand Name: WALGREENS
• Type of Device: ANTIBACTERIAL PADS
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota, fl
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota, fl
• Manufacturer Contact: federico juliao ; 300 sarasota center blvd.; sarasota, fl
• MDR Report Key: 10033439
• MDR Text Key: 190187601
• Report Number: 1038758-2020-00020
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#311917142272
• Device Catalogue Number: 153642
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other