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

Model Number UPC681131130264

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

Patient Problem Skin Irritation (2076)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2016 aso has not received a response from the consumer regarding the request for further information and return of unused samples.However, aso has verified records of biocompatibility testing and latex screening for the adhesives on materials used to manufacture the same type of products.Please refer to section of this report for further details.Aso will follow-up on this report as soon as the consumer provides further information.No information provided by consumer.

Event Description

Consumer reported that her skin was red after removing the bandage two days ago.Consumer stated she may seek medical attention.

Manufacturer Narrative

As of 08/10/2016 aso has not received a response from the consumer regarding the request for further information and return of unused samples.However, aso has verified records of biocompatibility testing and latex screening for the adhesives on materials used to manufacture the same type of products.Aso will follow-up on this report as soon as the consumer provides further information.As of 08/22/2016 aso received returned product from the customer and tested the product for adhesion.Results of the tests are acceptable with no defects found during testing.

Event Description

Consumer reported that her skin was red after removing the bandage two days ago.Consumer stated she may seek medical attention.

• Brand Name: EQUATE
• Type of Device: ANTIBACTERIAL ASSORTED ADHESIVE BANDAGES
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5867077
• MDR Text Key: 51814586
• Report Number: 1038758-2016-00088
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

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: 05/15/2021
• Device Model Number: UPC681131130264
• Device Catalogue Number: 554949049
• Device Lot Number: 00046551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 34 YR