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U.S. Department of Health and Human Services

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

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NURSE ASSIST, LLC NURSE ASSIST, LLC; 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW TOP BOTTLE Back to Search Results
Model Number 37-6270
Device Problem Contamination (1120)
Patient Problems Septic Shock (2068); Fungal Infection (2419)
Event Date 11/20/2023
Event Type  Death  
Event Description
On 28-nov-23, nurse assist received a medwatch report (mw5148357) via e-mail of the following event description from medwatch report: cder received the medwatch report.The reporter states the impacted individual had an ulcer wound that got infected with candida auris.They washed the wound daily with water.There were white spores (fungal growth) around the wounds.The hospital determined that candida auris got into the blood stream of the impacted individual and the individual went into septic shock and died.The reporter stated that they have the medical records for the deceased individual.Infection leading to death.
 
Manufacturer Narrative
We received a medwatch from the fda, but neither the anonymous reporter nor the fda would or could provide any information that would allow us to conduct a meaningful investigation.We are therefore filing an mdr based on the medwatch but cannot make any determination as to whether the reported event actually happened, and if it did whether it involved our products, and if it did whether those products actually contributed to the reported event.
 
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Brand Name
NURSE ASSIST, LLC
Type of Device
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 Key18387517
MDR Text Key331250695
Report Number3002695476-2023-00014
Device Sequence Number1
Product Code FRO
UDI-Device Identifier00612479199576
UDI-Public612479199576
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date 12/21/2023
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
Device Operator Lay User/Patient
Device Expiration Date08/11/2024
Device Model Number37-6270
Device Catalogue NumberN/A
Device Lot Number22083817
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/28/2023
Initial Date FDA Received12/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
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