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

Model Number	MA-1004-0500
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ecu charger malfunction - patient said 2 days ago when her device was on the charger, it got so hot to the point she could not touch it.She is very concerned that it will keep happening.
Additional Manufacturer Narrative
Bluewind medical is providing this report in compliance with fda 21cfr part 803.The device was replaced.As a result, a design history record review was performed and review of log from remote usage.While review of design control document and associated risks, labeling and other information from remote log of patient device were reviewed and cause was not established or problem could be with the device but until it is returned for investigation.The labeling identified the adverse event and caution statement related to the hot surface due to battery is adequate.

• Brand Name: REVI¿ WEARABLE DEVICE
• 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: 22639873
• Report Number: 3012239564-2025-00005
• Device Sequence Number: 9695225
• Product Code: QXM
• UDI-Device Identifier: 07290017912028
• UDI-Public: 07290017912028
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K240037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2025
• Device Model Number: MA-1004-0500
• Device Catalogue Number: MA-1004-0500
• 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: 06/30/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic