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

Model Number	69007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The caregiver was unable to provide the device lot number, and the used device will not be returned to the manufacturer for evaluation.Therefore, no device analysis can be conducted.Based on the available information, the event appears to have resulted from use error related to incorrect anatomical placement (vaginal insertion instead of rectal insertion).
Event or Problem Description
The manufacturer received a report involving a navina classic small rectal catheter in which the caregiver (mother) inadvertently inserted the rectal catheter into the patient's vagina instead of the rectum and inflated the balloon with two pumps.When the balloon was deflated, the patient experienced active vaginal bleeding and was taken to the emergency room.At the hospital, the patient underwent an exploratory diagnostic procedure to assess for possible uterine injury.No uterine perforation was identified, no surgical intervention was required, and the patient was monitored, treated for pain, and discharged.The patient subsequently completed a navina irrigation at the hospital without issue.

• Brand Name: NAVINA SYSTEM
• Common Device Name: NAVINA CLASSIC SYSTEM SMALL
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; molndal, SE-43 121; SW SE-43 121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; molndal, SE-43 121; SW SE-43 121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o.box 14; molndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 24412751
• Report Number: 3009632672-2026-00004
• Device Sequence Number: 12232344
• Product Code: KNT
• UDI-Device Identifier: 07392532243714
• UDI-Public: 07392532243714
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: 69007
• Device Catalogue Number: 6900740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female