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	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bluewind medical is providing this report in compliance with fda 21cfr part 803.The device was explanted.As a result, a design history record review was performed to confirm the sterility of the implant.Based on the documents reviewed and the interviews with physicians the implant location and positions appeared normal, with only mild peri-incisional erythema.
Event or Problem Description
Physician reached out to bluewind medical-rep to notify that patient is infected and she will be explanted implant the next day.Physician reported the following: patient had been seen at least twice if not 3 times post op and was on her third course of antibiotics and was progressing.According to md, purulence was emanating from the wound and signs of proximal infection up the leg were present in addition to persistent pain.Md made clinical decision to explant.Bluewind medical chief medical officer notes based on pictures taken before and during explant: photos showed no sign of proximal extension, no purulence either superficially or deep in the wound.A normal appearing implant location and positions, and only mild peri-incisional erythema.Device was explanted without consequence.Md made comments as to essentially non-problematic wound appearance.

• 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; 6 maskit street; herzliya, tel aviv 46140 02; IS 4614002
• Manufacturer Contact: roni diaz ; 6 maskit street; herzliya, tel aviv 46140-02 ; IS 4614002
• MDR Report Key: 20589983
• Report Number: 3012239564-2024-00003
• Device Sequence Number: 8943392
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K240037
• Exemption Number: 0000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2025
• Device Model Number: MA-1007-0600_US_CM
• Device Catalogue Number: MA-1007-0600_US_CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 76 YR
• Patient Sex: Female