MAUDE Adverse Event Report: BLUEWIND MEDICAL LTD. REVI SYSTEM; IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE

Model Number	KA-9000-0001_US_CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Skin Inflammation/ Irritation (4545)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported as delayed healing.The photo shows scabbing of the wound.There have been signs of improvement at times; however, the improvement has often been short-lived, and the infection has returned even after multiple rounds of antibiotics.Explanation completed.During the explantation, it did not appear that the actual implant was infected when taken out, and it was fully encapsulated.Date of explant on (b)(6) 2025.
Additional Manufacturer Narrative
Medical investigation - wound incision shows scabbing with no purulent discharge.The photo of the wound shows a rectangular skin reaction compatible with the skin reaction to the wound dressing.We believe explantation decision made by the patient and hcp was after a long time of delayed wound healing and was legitimate, but possibly removing the bandage, which may have caused the wound healing issues.Discussion with prof.Dmochowski (cmo) - no evidence of infection - suspected allergic reaction to wound dressing.

• Brand Name: REVI SYSTEM
• Common Device Name: IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE
• Manufacturer (Section D): BLUEWIND MEDICAL LTD.; 6 maskit street; herzliya, tel aviv 46140 02; IS 4614002
• Manufacturer (Section G): BLUEWIND MEDICAL LTD; 6 maskit street; herzliya, tel aviv 46140 02; IS 4614002
• Manufacturer Contact: himansu parikh ; 6 maskit street; herzliya, tel aviv 46140-02 ; IS 4614002
• MDR Report Key: 22779259
• Report Number: 3012239564-2025-00008
• Device Sequence Number: 18206886
• Product Code: QXM
• UDI-Device Identifier: 07290017912226
• UDI-Public: 07290017912226
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K240037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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 Model Number: KA-9000-0001_US_CM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female