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

Model Number	69005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3009632672-2023-00006
• Device Sequence Number: 20522883
• Product Code: KNT
• UDI-Device Identifier: 07392532198434
• UDI-Public: 07392532198434
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K190977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/02/2023

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 Model Number: 69005
• Device Catalogue Number: 6900515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: White