MAUDE Adverse Event Report: BIOPROTECT LTD BIOPROTECT BALLOON IMPLANT SYSTEM

Catalog Number	5135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Mfr report #: 3014285231-2026-00002 it was reported to bioprotect ltd.On (b)(6) 2026 that a bioprotect balloon implantation procedure was performed on (b)(6) 2026.The procedure was done under monitored anesthesia care (mac)following placement of fiducial markers and completed as expected.On simulation ct performed on (b)(6) 2026, the patient presented with a distended bladder.A foley catheter was placed and the patient was prescribed flomax.On (b)(6) 2026, the physician partially aspirated the balloon, and the catheter was removed.The patient's symptoms were relieved, and he started his radiation treatment as planned with no delay.

• Brand Name: BIOPROTECT BALLOON IMPLANT SYSTEM
• Common Device Name: BIOPROTECT BALLOON IMPLANT SYSTEM
• Manufacturer (Section D): BIOPROTECT LTD; 6 ha'gavish st.; netanya, fl 42450 706; IS 42450706
• MDR Report Key: 24613690
• Report Number: 3012602431-2026-00032
• Device Sequence Number: 18725692
• Product Code: OVB
• UDI-Device Identifier: 07290014878020
• UDI-Public: (01)07290014878020(11)250116(17)270115
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2026
• Report Date (Section F): 03/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5135
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• 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: Male
• Date Report Sent to FDA: 03/16/2026