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

Model Number UPC#681131052931

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

Patient Problem Rash (2033)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

Aso has evaluated retained samples of the same lot number.The results are acceptable with no defects found during testing.In addition, aso has reviewed records of biocompatibility tests and latex screening on adhesives.Aso will follow-up on this report if consumer provides further information.

Event Description

Consumer reported that after using bandage, it caused a rash.Consumer stated that bandage was tightly stuck to her skin.

Manufacturer Narrative

Aso has evaluated retained samples of the same lot number.The results are acceptable with no defects found during testing.In addition, aso has reviewed records of biocompatibility tests and latex screening on adhesives.Aso will follow-up on this report if consumer provides further information.As of 10/31/2016 aso has evaluated the unused returned sample.The results are acceptable with no defects found during testing.

Event Description

Consumer reported that after using bandage, it caused a rash.Consumer stated that bandage was tightly stuck to her skin.

• Brand Name: EQUATE
• Type of Device: ANTIBACTERIAL FLEXIBLE FABRIC XL 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: 6012779
• MDR Text Key: 56916917
• Report Number: 1038758-2016-00096
• 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: 09/09/2016

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: 05/05/2021
• Device Model Number: UPC#681131052931
• Device Catalogue Number: 551118202
• Device Lot Number: 00047387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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: 60 YR
• Patient Weight: 65