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

Model Number 69005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Sepsis (2067)

Event Date 09/06/2023

Event Type  Injury  

Event Description

A female patient, had surgery and irradiation for colorectal cancer a few years ago.The patient has currently anal prolapse and has issues with frequency and incomplete bowel emptying, for which she was prescribed transanal irrigation.The patient got a product instruction on (b)(6) from a nurse trainer.A follow-up telephone call between the nurse and the patient followed on (b)(6).The patient said that she was bleeding.The nurse advised her to have this urgently clarified by a doctor.The incident reported was on (b)(6), the nurse does not know whether the patient followed the advice and saw a doctor or continued the therapy between on (b)(6) since she could not reach the patient by phone during this week.The patient was alone when using the device and the rectal catheter balloon did not burst inside the rectum which normally is a cause of bowel perforation.According to the reported complaint, the patient injured her bowel so badly that emergency surgery was required.A large piece of the intestine was removed.The patient now has an artificial outlet.She was in an artificial coma (sedated), and she has been brought out of the coma.Because intestinal contents leaked into the abdominal cavity, there was severe sepsis plus damage to organs such as the heart, kidneys, and liver.According to the patient's daughter, the anastomosis from the colorectal cancer surgery is not the reason for the perforation.

Manufacturer Narrative

The product and product lo.No.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.

• Brand Name: NAVINA CLASSIC SYSTEM
• Type of Device: NAVINA CLASSIC SYSTEM REGULAR
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o.box 14; molndal SE-43-121 ; SW SE-43121
• MDR Report Key: 17849685
• MDR Text Key: 324660644
• Report Number: 3009632672-2023-00006
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 07392532198434
• UDI-Public: 07392532198434
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K190977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• 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
• Date Manufacturer Received: 09/11/2023
• 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: 79 YR
• Patient Sex: Female
• Patient Race: White