MAUDE Adverse Event Report: ASO LLC KROGER; ANTIBACTERIAL SHEER ADHESIVE PADS

Model Number UPC#041260384127

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

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

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

As of 08/16/2021 unused retained product was submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.

Event Description

On the initial report on 07/20/2021 consumer stated that had a reaction after using the product and developed blisters.Consumer added medical attention was sought.

Manufacturer Narrative

As of 08/16/2021 unused retained product was submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.Refer to section b.6 of this report for further details.As of 09/09/2021 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.

Event Description

On the initial report on 07/20/2021 consumer stated that had a reaction after using the product and developed blisters.Consumer added medical attention was sought.On completed cir received on 08/17/2021 consumer stated that the doctor stated the product caused an unspecified contact dermititis.The symptoms were improving gradually, but he still has the rectangle mark of the contour of the product on his skin.

• Brand Name: KROGER
• Type of Device: ANTIBACTERIAL SHEER ADHESIVE PADS
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd; sarasota FL 34240
• MDR Report Key: 12332837
• MDR Text Key: 266947041
• Report Number: 1038758-2021-00028
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#041260384127
• Device Catalogue Number: 34324
• Device Lot Number: 00142533
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other