MAUDE Adverse Event Report: NURSE ASSIST, LLC NURSE ASSIST, LLC; 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW TOP BOTTLE

Model Number	37-6270
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07-nov-23, nurse assist received a complaint via e-mail from canbin ma of the following event description from e-mail: after using the 0.9% sodium chloride solution, i noticed a significant skin irritation, which led to swelling, as evidenced in the attached image.This is a condition i have never experienced before, and it has caused me significant discomfort and concern.Given the severity of my reaction and the fact that no such symptom has ever occured to me prior to using the product, i kindly request your assistance in resolving this matter.

• Brand Name: NURSE ASSIST, LLC
• Common Device Name: 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW TOP BOTTLE
• Manufacturer (Section D): NURSE ASSIST, LLC; 4409 haltom rd.; haltom city 76117
• Manufacturer (Section G): NURSE ASSIST, LLC; 4409 haltom rd.; haltom city TX 76117
• Manufacturer Contact: anthony bui ; 4409 haltom rd.; haltom city, TX 76117 ; 8006496800
• MDR Report Key: 18400825
• Report Number: 3002695476-2023-00015
• Device Sequence Number: 2699208
• Product Code: FRO
• UDI-Device Identifier: 00612479199576
• UDI-Public: 612479199576
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/14/2024
• Device Model Number: 37-6270
• Device Catalogue Number: N/A
• Device Lot Number: 23076043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown