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

Model Number	MA-1007-0600_US_CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted on (b)(6) 2025.On (b)(6) 2026, bwm was informed that the patient experienced delayed wound healing, inflammation, and a potential infection at the incision site.The patient was treated with two courses of antibiotics, after which the incision color returned to normal; however, an opening remained at the incision site.The treating physician subsequently evaluated the incision and determined that it was healing appropriately, with no restrictions on activities, including pool use.The patient was advised to continue revi treatment.As of (b)(6) 2026, the infection appeared to be resolved following antibiotic treatment, with no remaining concerns reported.
Additional Manufacturer Narrative
On (b)(6) 2026, the treating physician evaluated the incision site; patient was instructed to continue revi treatments.Infection appears to have been successfully treated with no remaining concerns.

• Brand Name: REVI SYSTEM
• Common Device Name: IMPLANTED TIBIAL ELECTRICAL URINARY
• Manufacturer (Section D): BLUEWIND MEDICAL LTD; 6 maskit street isra; herzliya, 46140 02; IS 4614002
• Manufacturer (Section G): ANGEL ESTRADA; 6 maskit street.; p.o. box 4100; herzliya, 46140 2; IS 461402
• Manufacturer Contact: angel estrada ; 1389 center drive suite 200; park city, UT 84098 ; 7742842463
• MDR Report Key: 24746352
• Report Number: 3012239564-2026-00019
• Device Sequence Number: 9166097
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K240037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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
• Device Model Number: MA-1007-0600_US_CM
• Device Catalogue Number: MA-1007-0600_US_CM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female