MAUDE Adverse Event Report: BLUEWIND MEDICAL LTD REVI SYSTEM; IMPLANTED TIBIAL ELECTRICAL URINARY, PRODUCT CODE: QXM

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	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This patient has an infection and believes there is no relation to the implant or revi.Patient has had urethral bleeding and worried about bladder cancer an believes co morbidities was the issue.She is probably not a good candidate for surgery in general with her co morbidities.

• Brand Name: REVI SYSTEM
• Common Device Name: IMPLANTED TIBIAL ELECTRICAL URINARY, PRODUCT CODE: QXM
• Manufacturer (Section D): BLUEWIND MEDICAL LTD; 6 maskit street; buliduing b; herziliya, israel 46140 02; IS 4614002
• Manufacturer (Section G): BLUEWIND MEDICAL LTD; 6 maskit street.; p.o. box 4100 herzliya 461402,; herzliya, israel 46140 2; IS 461402
• Manufacturer Contact: angel estrada ; 1389 center drive suite 200; park city, ut 84098, usa; park city, UT ; 7742842463
• MDR Report Key: 25200662
• Report Number: 3012239564-2026-00025
• Device Sequence Number: 8873014
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K240037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Female