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	07/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported open wound at incision site with drainage.The treating physician determined there were signs of infection and the following actions were taken: a wound culture was completed and showed 2 strains of pseudomonas aeruginosa.The patient was prescribed bactrim.The physician removed the implant on (b)(6) 2024 under iv sedation.The patient is currently recovering with no long-term complications anticipated.
Additional Manufacturer Narrative
Bluewind medical is providing this report in compliance with fda 21cfr part 803.The device was explanted; however, no explanted product was returned for analysis.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 infection was superficial and not a deep infection that involved the implant.

• 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: roni diaz ; 1389 center drive; suite 200; park city, UT 84098 ; 8887152080
• MDR Report Key: 20027277
• Report Number: 3012239564-2024-00001
• Device Sequence Number: 8566647
• Product Code: QXM
• UDI-Device Identifier: 07290017912011
• UDI-Public: 07290017912011
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K240037
• 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): 08/16/2024

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: 09/01/2024
• Device Model Number: MA-1007-0600_US_CM
• Device Catalogue Number: MA-1007-0600_US_CM
• Device Lot Number: N/A
• 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: 07/20/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COSOPT 1 DROP QD FOR GLAUCOMA; GEMTESA 75MG PO FOR UUI/OAB; ROCKLATAN 1 DROP FOR GLAUCOMA; SYNTHROID 125MCG PO FOR THYROID DISEASE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian