MAUDE Adverse Event Report: ASO LLC TOPCARE; STRONG-STRIPS ADHESIVE BANDAGES ANTIBACTERIAL

Model Number UPC#036800403031

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2019 aso reviewed records of biocompatibility tests.Aso haven't received response, returned product or lot number of the referred product.

Event Description

On the initial report on (b)(6) 2019 consumer reported had a reaction to the adhesive part of the product.Consumer added that 3 months later she still has a mark with the shape of one side of the bandage on her arm.

Manufacturer Narrative

As of 09/23/2019 aso reviewed records of biocompatibility tests.Aso haven't received response, returned product or lot number of the referred product.Refer to section b.6 of this report for further details.On (b)(6) 2020 testing results on retained samples were satisfactory with no defects noted.Refer to section b.6 of this report for further details.The following sections were updated: b.6, d4, h.6 (codes removed: 3221 and 11.Codes added: 2993, 213, 11 and 67).

Event Description

On the initial report on (b)(6) 2019 consumer reported had a reaction to the adhesive part of the product.Consumer added that 3 months later she still has a mark with the shape of one side of the bandage on her arm.

• Brand Name: TOPCARE
• Type of Device: STRONG-STRIPS ADHESIVE BANDAGES ANTIBACTERIAL
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• MDR Report Key: 9119388
• MDR Text Key: 161958914
• Report Number: 1038758-2019-00040
• 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: 01/23/2020

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 Operator: No Information
• Device Expiration Date: 05/23/2023
• Device Model Number: UPC#036800403031
• Device Catalogue Number: 003680040303
• Device Lot Number: 00085675
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other