MAUDE Adverse Event Report: ASO LLC EQUATE; EXTRA STRENGTH CLEAR NASAL STRIPS

Model Number UPC#681131112185

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

Aso evaluated returned samples as well as retained samples of the same lot number.In addition, aso reviewed records of biocompatibility tests.

Event Description

Consumer reported that nasal strips gave her a rash on her nose, chin and under her eye on the 7th day of use.

• Brand Name: EQUATE
• Type of Device: EXTRA STRENGTH CLEAR NASAL STRIPS
• 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
• MDR Report Key: 6541794
• MDR Text Key: 74332420
• Report Number: 1038758-2017-00014
• 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
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/22/2022
• Device Model Number: UPC#681131112185
• Device Catalogue Number: 553994071
• Device Lot Number: 00061232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 57