MAUDE Adverse Event Report: ASO LLC WALGREENS; FLEXIBLE FABRIC BANDAGES

Model Number UPC#311917190334

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

Patient Problems Rash (2033); Wheal(s) (2241)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

As of 06/28/2021 unused retained samples of the same lot reported were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests.

Event Description

On the initial report received by aso on 06/03/2021 consumer informed that she had a rash where she applied the bandage.She added she sought medical attention as she had raise whelps were the adhesive was.

Manufacturer Narrative

As of (b)(6) 2021 unused retained samples of the same lot reported were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests.Refer to section b.6 of this report for further details.As of (b)(6) 2021 returned product samples were submitted to the lab for testing with no defects noted.Refer to section b.6 of this report for further details.Updated to add code 4101 due to receipt of customer returned products, again no issues noted.

Event Description

On the initial report received by aso on (b)(6) 2021 consumer informed that she had a rash where she applied the bandage.She added she sought medical attention as she had raise whelps were the adhesive was.On (b)(6) 2021 we received completed cir from consumer, she stated the reaction was from the adhesive around the pad area.

• Brand Name: WALGREENS
• Type of Device: FLEXIBLE FABRIC BANDAGES
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• MDR Report Key: 12107417
• MDR Text Key: 259639958
• Report Number: 1038758-2021-00022
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#311917190334
• Device Catalogue Number: 977767
• Device Lot Number: 00114335
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other