MAUDE Adverse Event Report: ASO LLC CARDINAL HEALTH; NASAL DILATOR TRIPLE BRIDGE TAN

Model Number UPC096295124286

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

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 manufactured with the same materials.Aso has made a first attempt to contact the end user on 11/20/2015 and a second attempt on 12/7/2015 but no response has yet been received.

Event Description

End user reported that when he removed device in the morning, it took off his top layer of skin.

Manufacturer Narrative

Refer to section for test results.

• Brand Name: CARDINAL HEALTH
• Type of Device: NASAL DILATOR TRIPLE BRIDGE TAN
• 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: 5286887
• MDR Text Key: 33204688
• Report Number: 1038758-2015-00115
• Device Sequence Number: 1
• Product Code: LWF
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/30/2019
• Device Model Number: UPC096295124286
• Device Catalogue Number: 4904215
• Device Lot Number: 8210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1