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

Model Number	6281
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Date of Event	04/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch report mw5149042.
Event or Problem Description
On 13-dec-23, nurse assist received a medwatch report via e-mail of the following event description from medwatch report: i had tummy tuck surgery on (b)(6) 2023.To help prevent infection and help with healing, my doctor suggested to order this product.I ordered it five times-april 1, april 10, april 23, may 7 and july 23 all of which i have receipts for via amazon.After seeing separation of my scar on (b)(6) that is when i ordered it.After using it for only 3 days, my incision became more open and displaying signs of infection.On (b)(6), it came completely open and, with my doctors recommendation, he stated to keep using the saline and stuffing it to help promote healing and prevent infection.I continued doing this until (b)(6) which at that time, i went back into my doctor for an incision revision due to it healed improperly during the times i was using this product.

• 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: anthony bui ; 4409 haltom rd.; haltom city, TX 76117 ; 8006496800
• MDR Report Key: 18475007
• Report Number: 3002695476-2023-00043
• Device Sequence Number: 6407523
• Product Code: FRO
• UDI-Device Identifier: 00850421008846
• UDI-Public: (01)00850421008846
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/29/2023

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: 05/31/2025
• Device Model Number: 6281
• Device Lot Number: 23055720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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