MAUDE Adverse Event Report: ASO LLC CVS; ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES EXTRA LARGE SIZE

Model Number UPC#050428560792

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

Patient Problems Abrasion (1689); Skin Inflammation/ Irritation (4545)

Event Date 05/23/2023

Event Type  Injury  

Event Description

On the initial report received by aso on 04/24/2023, the consumer stated that she used the bandages on her incision and caused irritation every time she used them.She said that the adhesive also removed some of her skin.On 05/23/2023, we received the completed customer information request from the consumer.The consumer went to the doctor to have staples removed, and dr.Took a look at the irritation and told her to stop using the bandage immediately.Dr.Recommends that the consumer use cortisone cream all over the irritated area.

Manufacturer Narrative

As of 06/08/2023 retained samples of the same lot product 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.

Event Description

On the initial report received by aso on 04/24/2023, the consumer stated that she used the bandages on her incision and caused irritation every time she used them.She said that the adhesive also removed some of her skin.On 05/23/2023, we received the completed customer information request from the consumer.The consumer went to the doctor to have staples removed, and dr.Took a look at the irritation and told her to stop using the bandage immediately.Dr.Recommends that the consumer use cortisone cream all over the irritated area.

Manufacturer Narrative

As of 06/08/2023 retained samples of the same lot product 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 8/10/2023 aso received the unused product from the consumer.Returned product samples were submitted to the lab with no defects noted.

• Brand Name: CVS
• Type of Device: ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES EXTRA LARGE SIZE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.
• MDR Report Key: 17111816
• MDR Text Key: 317114744
• Report Number: 1038758-2023-00013
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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 Model Number: UPC#050428560792
• Device Lot Number: 00177158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2023
• 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
• Patient Sex: Female