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

Model Number	6270
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint (b)(4) from medwatch mw5154072.Reached out to patient on 5/8/24 for additional information.
Event or Problem Description
From medwatch report (mw5154072): used nurse assist stericare part # 6270 250ml sterile saline solution on open leg wound before i was notified by amazon of the recall.Wound healing required more medical assistance than initially projected.Used the saline to wash on open leg wound 2x/day as doctor.

• Brand Name: NURSE ASSIST, LLC
• Common Device Name: 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP,
• Manufacturer (Section D): NURSE ASSIST, LLC; 4409 haltom rd.; haltom city TX 76117
• Manufacturer (Section G): NURSE ASSIST, LLC; 4409 haltom rd.; haltom city TX 76117
• Manufacturer Contact: rebeca masdon-mercado ; 4409 haltom rd.; haltom city, TX 76117 ; 8006496800
• MDR Report Key: 19333447
• Report Number: 3002695476-2024-00025
• Device Sequence Number: 3101985
• Product Code: FRO
• UDI-Device Identifier: 00850421008822
• UDI-Public: 850421008822
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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 Expiration Date: 05/17/2025
• Device Model Number: 6270
• Device Catalogue Number: N/A
• Device Lot Number: 23055604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown