MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA CLASSIC; NAVINA CLASSIC SYSTEM REGULAR

Model Number 69005

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/17/2022

Event Type  Injury  

Manufacturer Narrative

The product was not available to be returned.Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.

Event Description

A (b)(6) female patient has been using the navina classic rectal irrigation system since (b)(6) 2022.In (b)(6) 2022, the female patient was brought to the hospital in the city (b)(6) as an emergency and was operated 2 days later due to an intestinal obstruction.After the incident wellspect healthcare sales representative reached out to the patient.The patient briefly described that the doctor thought that too much water could have been used during irrigation.When our sales representative asked her how many pumps she had irrigated, she did not know exactly, but estimated to be 6-8.Therefore, the question remains and cannot be answered how much water has been instilled, since the patient is blind and no healthcare provider was not present during irrigation therapy.According to the patient she has previously underwent 4 other intestinal surgeries prior to this incident and currently has poor blood values furthermore a hole was also discovered in the diaphragm where the stomach is trapped.The doctor visits her every 2 days and she is currently receiving 5 times the dose of morphine.

• Brand Name: NAVINA CLASSIC
• Type of Device: NAVINA CLASSIC SYSTEM REGULAR
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; molndal, vastra gotalands lan SE-43 121; SW SE-43121
• Manufacturer Contact: dino ohranovic ; aminogatan 1; p.o box 14; molndal, vastra gotalands lan SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 14591482
• MDR Text Key: 293257773
• Report Number: 3009632672-2022-00001
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K190977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2022

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 Model Number: 69005
• Device Catalogue Number: 6900515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female