MAUDE Adverse Event Report: BioProtect Ltd. BioProtect Balloon Implant System

Model Number	5135
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury

• Brand Name: BioProtect Balloon Implant System
• Common Device Name: BioProtect Balloon Implant System
• Manufacturer (Section D): BioProtect Ltd.; 6 ha'gavish st; netanya 42507 06; IS 4250706
• MDR Report Key: 50747513
• Report Number: 3012602431-2026-00088
• Device Sequence Number: 18358344
• Product Code: OVB
• UDI-Device Identifier: 07290014878020
• UDI-Public: (01)07290014878020(11)250514(17)270513
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 04/21/2026
• Report Date (Section F): 04/21/2026

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: 5135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2026
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/11/2026