MAUDE Adverse Event Report: ASO LLC EQUATE; FABRIC ANTIBACTERIAL BANDAGE

Model Number UPC681131065580

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2015 aso was unable to test the device as no lot number was provided or returned samples from end user.Aso reviewed satisfactory biocompatibility reports on products manufctured with the same materials.Refer to of this report for details.Aso has made a first attempt to contact the end user on (b)(6) 205 and a second attempt on (b)(6) 2015 but no response has yet been received.End user did not provide information.

Event Description

End user reported that the device ripped off her skin when she removed it from her wound.The wound was not affected, healthy skin surrounding the wound was.No medical attention was sought out.

Manufacturer Narrative

Aso received returned samples on 12/14/2015.Aso performed adhesion test on returned samples and retained samples of same lot number.Refer to this report for details on test results.

• Brand Name: EQUATE
• Type of Device: FABRIC ANTIBACTERIAL BANDAGE
• 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: 5289544
• MDR Text Key: 33279480
• Report Number: 1038758-2015-00116
• 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: 11/19/2015

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: 09/30/2020
• Device Model Number: UPC681131065580
• Device Catalogue Number: 551640698
• Device Lot Number: 37040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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: 53 YR
• Patient Weight: 107