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

Model Number UPC#681131006712

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

Patient Problems Abrasion (1689); Skin Irritation (2076); Wheal(s) (2241)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

As of 10/09/2019 unused retained samples of the same lot were submitted to the lab for testing with no defects noted.Aso reviewed records of biocompatibility tests.No returned product samples have been received from consumer.

Event Description

On the initial report on (b)(6) 2019 consumer reported had an allergic reaction to the bandages, she added product caused her skin to be red, itchy, and blistered (atopic dermatitis).She also reported that upon removal the bandage also tore her skin.Consumer stated sought medical attention and was prescribed neosporin.

Manufacturer Narrative

As of 10/09/2019 unused retained samples of the same lot were submitted to the lab for testing with no defects noted.Aso reviewed records of biocompatibility tests.Refer to relevant tests.Lab data (including dates) of this report for further details.No returned product samples have been received from consumer.As of 12/13/2019 unused returned samples were submitted to the lab for testing with no defects noted.The following was updated: (codes removed 2533, 4114 and 4316).

Event Description

On the initial report on (b)(6) 2019 consumer reported had an allergic reaction to the bandages, she added product caused her skin to be red, itchy, and blistered (atopic dermatitis).She also reported that upon removal the bandage also tore her skin.Consumer stated sought medical attention and was prescribed neosporin.On (b)(6) 2019 we received from consumer completed cir and returned samples.Consumer stated the issue was with the tape area.

• Brand Name: EQUATE
• Type of Device: FLEXIBLE FABRIC ASSORTED BANDAGES ANTIBACTERIAL
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• MDR Report Key: 9173051
• MDR Text Key: 161740338
• Report Number: 1038758-2019-00045
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2023
• Device Model Number: UPC#681131006712
• Device Catalogue Number: 566928030
• Device Lot Number: 00098799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other