MAUDE Adverse Event Report: ASO LLC WALGREENS; HEAVY DUTY FABRIC BANDAGES

Model Number UPC#311917195209

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2020 unused retained samples of the same lot as the product reported and returned product were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests and latex screening with no issues noted.

Event Description

On the initial report of 03/31/2020 consumer stated that product caused an allergic reaction.On cir received on 04/07/2020 consumer added was prescribed antibiotics, neosporin & benadryl; and stated that still has a faded mark of the bandage and itchiness on the affected area.

• Brand Name: WALGREENS
• Type of Device: HEAVY DUTY FABRIC BANDAGES
• 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: 10010511
• MDR Text Key: 189453714
• Report Number: 1038758-2020-00018
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#311917195209
• Device Catalogue Number: 877902
• Device Lot Number: 00115162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2019
• 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