MAUDE Adverse Event Report: PRAMAND, LLC CRANISEAL DURAL SEALANT

Model Number	CS-2055
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 45-year-old female underwent craniotomy for a benign tumor on (b)(6) 2025.No procedural complications or aes were noted.At discharge on (b)(6) 2025, there was normal wound healing and no evidence of csf leak.On (b)(6) 2025 during the 30-day follow-up, it was noted that she has some mild-drainage at the end of the incision line and went on antibiotics.She noted that there wasn't drainage however in the week leading up to this.Patient went to er on (b)(6) 2025 due to purulent drainage and was admitted; patient was taken to or on (b)(6) 2025 for incision and drainage.Subject was discharged on (b)(6) 2025 without further complication.

• Brand Name: CRANISEAL DURAL SEALANT
• Common Device Name: DURAL SEALANT
• Manufacturer (Section D): PRAMAND, LLC; 201 burlington rd; north building, second floor; bedford MA 01730
• Manufacturer (Section G): PRAMAND, LLC; 201 burlington rd; north building, second floor; bedford MA 01730
• Manufacturer Contact: julia doroshenko ; 201 burlington rd; north building, second floor; bedford, MA 01730 ; 7815401626
• MDR Report Key: 22235758
• Report Number: 3016980830-2025-00002
• Device Sequence Number: 8185661
• Product Code: NQR
• UDI-Device Identifier: 00860010683705
• UDI-Public: 00860010683705
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P220014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/17/2025

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?: No
• Device Expiration Date: 04/19/2025
• Device Model Number: CS-2055
• Device Lot Number: PRA-PD-0102
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 127 KG