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

Model Number UPC#681131112185

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

Patient Problems Skin Irritation (2076); Wheal(s) (2241)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

The initial complaint received on (b)(6) 2020 did not indicate that an mdr would be required.However, the consumer stated on returned cir received on (b)(6) 2020 that medical treatment was required.Based on the information received, aso opted to file an mdr.As of (b)(6) 2020 unused returned product and retained samples of the same lot were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests and latex screening.

Event Description

On the initial report received on (b)(6) 2020 consumer stated the nasal strip caused her a reaction.On (b)(6) 2020 reporter stated on returned cir that medical treatment was sought, based on this information received, aso opted to file an mdr.

• Brand Name: EQUATE
• Type of Device: EXTRA STRENGTH NASAL STRIPS
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota, fl
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota, fl
• Manufacturer Contact: federico juliao ; 300 sarasota center blvd.; sarasota, fl
• MDR Report Key: 10203781
• MDR Text Key: 196970464
• Report Number: 1038758-2020-00027
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#681131112185
• Device Catalogue Number: 564118458
• Device Lot Number: 00123843
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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 Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 113