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	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted on (b)(6) 2026.On 04 march 2026, bwm became aware that the patient developed mild cellulitis.As a result, treatment was suspended, and the patient was prescribed oral antibiotics.On (b)(6) 2026, the patient was referred for wound care, where the incision site was treated with a silver alginate dressing.

• 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: 24745030
• Report Number: 3012239564-2026-00018
• Device Sequence Number: 9229951
• 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: 2026
• 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 Sex: Female