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

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	06/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bluewind medical is providing this report in compliance with fda 21cfr part 803.Surgical site infection (ssi) - although no comorbidities acknowledged, this patient suffered from a surgical site infection.Possibly could have been treated with repeat wound debridement and bandaging, as the patient was planning to go on a cruise vacation, hcp decided it is more reasonable to explant as wound handling wound not be optimal during a cruise vacation.Surgical site infections are known and expected events in patients undergoing foot and ankle surgery.A recent review found the incidence of ssi for patient undergoing foot and ankle surgeries may be up to 6.5% of cases.Https://www.Sciencedirect.Com/science/article/abs/pii/s0958259224000257.
Event or Problem Description
Patient states he went to the er (b)(6) due to infection at the incision site.He was given antibiotics and sent home to schedule explant as er doctor was hesitant to explant due to patient being on blood thinners.Patient called to inform he is being explanted (b)(6) at 7:15am by dr.(b)(6).He is a patient of dr.(b)(6), but dr.(b)(6) is out of town.On (b)(6) 2025: patient was explanted without issues; a culture was taken due to active infection; patient was given 7-day course of antibiotics post-surgery and will follow up in clinic (b)(6) with (b)(6), dr.(b)(6) pa.Patient is leaving for a cruise vacation (b)(6).Patient wanted to try to salvage implant, but dr.(b)(6) thought best to explant due to patient's upcoming cruise.Implant was collected in a biohazard bag.

• 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: 22672220
• Report Number: 3012239564-2025-00006
• Device Sequence Number: 18011642
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• 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): 07/30/2025

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: 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: 06/28/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male