MAUDE Adverse Event Report: NURSE ASSIST, LLC NURSE ASSIST; STERILE WATER FOR IRRIGATION USP IN SCREW TOP BOTTLE

Model Number	6240
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint (b)(4) from medwatch mw5153672.
Event or Problem Description
From medwatch report (mw5153672).Had rhinoplasty and septoplasty.Saline used after procedure for cleaning.One month later, abscess was present and had to have another surgery to clear abscess.Nose is now deformed.

• Brand Name: NURSE ASSIST
• Common Device Name: STERILE WATER FOR IRRIGATION USP IN SCREW TOP BOTTLE
• 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: 19201738
• Report Number: 3002695476-2024-00021
• Device Sequence Number: 8072844
• Product Code: FRO
• UDI-Device Identifier: 00850421008815
• UDI-Public: 850421008815
• 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): 04/23/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/20/2025
• Device Model Number: 6240
• Device Lot Number: 23045346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2023
• 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: Life Threatening; Required Intervention; Disability
• Patient Sex: Unknown