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)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to bioprotect ltd.That a bioprotect balloon implantation procedure was performed on (b)(6) 2026.Ultrasound visualization was poor due to patient's insufficient bowel preparation and thin rectal wall.Digital rectal examination (dre) and ct following the procedure confirmed the balloon was placed in the lumen of the rectum.The patient was referred to a local er where the balloon was subsequently aspirated and removed.A 5 mm puncture in the rectal wall was repaired by a colorectal surgeon.The patient is expected to receive a replacement spacer, and his radiation treatment was delayed.

• 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,
• Manufacturer (Section G): BIOPROTECT LTD; 6 ha'gavish st.; netanya, 42507 06; IS 4250706
• Manufacturer Contact: noga avisar ; 6 ha'gavish st.; netanya, 42507-06 ; IS 4250706
• MDR Report Key: 25216898
• Report Number: 3014285231-2026-00010
• Device Sequence Number: 21276840
• 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
• PMA/510(K) Number: K222972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male