MAUDE Adverse Event Report: ASO LLC EQUATE; FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL

Model Number UPC#681131228350

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

Patient Problems Abrasion (1689); Hypersensitivity/Allergic reaction (1907)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

As of 09/08/2021 unused retained samples were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests and latex screening.

Event Description

On the initial report received by aso on 08/13/2021 consumer reported the product caused an allergic reaction.She stated sought medical attention.Consumer explained she applied a 1st bandage (3/4 strip) and this product tore her skin upon removal; then the consumer added she applied a 2nd bandage (xl strip) that caused blistering and a burn like reaction.For this report we will refer to the first product.And will refer to the 2nd product on report 1038758-2021-00031.

Event Description

On the initial report received by aso on (b)(6) 2021 consumer reported the product caused an allergic reaction.She stated sought medical attention.Consumer explained she applied a 1st bandage (3/4 strip) and this product tore her skin upon removal; then the consumer added she applied a 2nd bandage (xl strip) that caused blistering and a burn like reaction.For this report 1038758-2021-00030 we will refer to the first product.And will refer to the 2nd product on report 1038758-2021-00031.On completed cir received on (b)(6) 2021, consumer stated that the issue was with both tape and pad.Consumer added that she cleaned the affected area with water and covered them with liquid bandage.

Manufacturer Narrative

As of (b)(6) 2021 unused retained samples were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests and latex screening.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.

• Brand Name: EQUATE
• Type of Device: FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• MDR Report Key: 12447973
• MDR Text Key: 271915865
• Report Number: 1038758-2021-00030
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#681131228350
• Device Catalogue Number: 566944586
• Device Lot Number: 00149056
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 67