MAUDE Adverse Event Report: PRAMAND, LLC CRANISEAL DURAL SEALANT

Model Number	PRA-PROD-0001
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Subject was seen by dr.(b)(6) on (b)(6) 2026 with complaints of swelling across his surgical incision site that started three days prior.Reports localized tenderness and denies fever.Reports that since surgery he experiences head pressure and cognitive fogginess.Subject was sent for ct imaging on (b)(6) 2026, that confirmed csf leak.Subject denies any activities that increase intracranial pressure.Subject is scheduled for revision surgery on (b)(6) 2026.Repair surgery performed on (b)(6) 2026.Several valsalva maneuvers were conducted to find the leak, but none was noted.Watertight closure was achieved, with no csf leak following wound closure, no complications.

• Brand Name: CRANISEAL DURAL SEALANT
• Common Device Name: DURAL SEALANT
• Manufacturer (Section D): PRAMAND, LLC; 201 burlington road; north building, second floor; bedford MA 01730
• Manufacturer (Section G): PRAMAND; 201 burlington road; north building, second floor; bedford MA 01730
• Manufacturer Contact: ezekiel cruz ; 201 burlington road; north building, second floor; bedford, MA 01730 ; 2039707894
• MDR Report Key: 24746290
• Report Number: 3016980830-2026-00016
• Device Sequence Number: 21027693
• Product Code: NQR
• UDI-Device Identifier: 00860010683705
• UDI-Public: 00860010683705
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P220014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/31/2026

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 Expiration Date: 06/05/2026
• Device Model Number: PRA-PROD-0001
• Device Catalogue Number: CS-2055
• Device Lot Number: PRA-PD-0140
• 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: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BONE CEMENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White