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

Model Number	69013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	04/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device complaint was initiated following notification of the patient's hospitalization.No product samples were returned; therefore, physical examination and functional testing of the device could not be performed.Batch manufacturing records were reviewed, and no deviations, nonconformities, or quality issues were identified.Based on the information available, there is no evidence of device malfunction, device failure, or use error.The irrigation volumes reported by the patient are within expected use parameters.The patient did not report acute severe pain, rectal bleeding, or injury during balloon inflation or irrigation.Clinical evaluation, including ct imaging and laboratory testing, did not identify bowel perforation, infection, sepsis, or other injury attributable to the device.The patient has significant pre-existing gastrointestinal conditions, including known rectal intussusception and a newly identified redundant cecum, which are considered plausible contributing factors to the reported abdominal pain and hospitalization.The event appears to be temporally associated with use of the navina classic system; however, based on the available clinical information and device evaluation, a causal relationship between the device and the reported medical event could not be established.
Event or Problem Description
A 63 year old female patient with a history of chronic bowel dysfunction, known rectal intussusception, and severe constipation was using the navina classic bowel irrigation system with a regular rectal balloon catheter for bowel management.The patient had been prescribed navina in (b)(6) 2025 and started using the system in (b)(6) 2026, reporting positive therapeutic benefit and reduced emergency department visits.On (b)(6) 2026, at approximately 11:00 am, the patient performed her most recent bowel irrigation using the navina classic system.The irrigation consisted of split administrations approximately 15 minutes apart, with an estimated irrigation volume of 100-200 ml during the first irrigation and 300-400 ml during the second irrigation.Brown effluent was expelled following irrigation, which is consistent with stool evacuation.The patient reported intermittent abdominal discomfort during irrigation, which she stated is typical for her and occurs both with and without use of the device.Approximately two hours after completion of irrigation, the patient developed increasing lower abdominal pain.No rectal bleeding was reported.The pain worsened overnight.On the morning of (b)(6) 2026, the patient experienced sweating and recorded a fever of 102.5°f at home.No antipyretic medications were taken.The patient presented to the emergency department at approximately 9:30-10:00 am and was admitted for observation.Upon arrival, the patient was afebrile.Diagnostic evaluations included a ct scan of the abdomen and pelvis and a chest x-ray.The ct scan identified a redundant cecum (new diagnosis per the patient) and a moderate stool burden.No bowel perforation, obstruction, free air, or other acute bowel injury was identified.The chest x-ray was reported as normal.Laboratory results and imaging did not demonstrate evidence of sepsis, bowel perforation, or device related injury.The patient remained hospitalized for observation and was clinically stable with discussions regarding discharge as of (b)(6) 2026.The patient planned outpatient follow up with a colorectal surgeon.

• Brand Name: NAVINA CLASSIC SYSTEM
• Common Device Name: NAVINA CLASSIC SYSTEM REGULAR
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; mölndal, se-43 121, mölndal, sweden ; SW
• Manufacturer (Section G): WELLSPECT HELATHCARE; aminogtan 1; mölndal, se-43 121 mölndal ; SW
• Manufacturer Contact: emad ramzi ; aminogtan 1; mölndal, se-43 121 mölndal ; SW
• MDR Report Key: 24949835
• Report Number: 3009632672-2026-00015
• Device Sequence Number: 12081910
• Product Code: KNT
• UDI-Device Identifier: 07333387028330
• UDI-Public: 07333387028330
• Combination Product (Y/N): N
• PMA/510(K) Number: K190977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 69013
• Device Catalogue Number: 6901340
• Device Lot Number: 670562
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (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: 63 YR
• Patient Sex: Female