MAUDE Adverse Event Report: Pramand, LLC CraniSeal Dural Sealant

Model Number	PRA-PROD-0007
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2026, dose audit samples were irradiated for a routine dose audit, with sterility testing beginning (b)(6)2026 at (b)(6).By day 7, 5 of the 10 samples exhibited growth and the final 5 samples were inadvertently discarded before the full 14-day incubation period was completed which rendered the sterility test invalid.Samples from the same lote were retested and confirmed to pass sterility testing.Root cause of the failure has not yet been fully determined and the investigation is still on-going.No events have been reported related to patient harm.
Additional Manufacturer Narrative
Pramand is conducting an investigation on the invalid dose audit.Pramand consulted a sterilization expert who determined that the results of the test of sterility suggested a lab error and are considered invalid based upon available bioburden results from the test lab, test of sterility results, and identification of the positives.It was recommended that the test of sterility should be repeated due to the test lab's error in discarding the remaining samples from the dose audit.Pramand repeated the test of sterility with the same material from the same lot, and the lot met all specifications.The investigations of pramand, the sterilizer, and the test lab are still ongoing, with no root cause determined yet.

• Brand Name: CraniSeal Dural Sealant
• Common Device Name: Dural Sealant
• Manufacturer (Section D): Pramand, LLC; 201 burlington road; bedford MA 01730 -140
• Manufacturer (Section G): Pramand, LLC; 201 burlington road; bedford MA 01730 -146
• Manufacturer Contact: ezekiel cruz ; 201 burlington road; bedford, MA 01730--146 ; +1(203)970-7894
• MDR Report Key: 50484241
• Report Number: 3016980830-2026-00004
• Device Sequence Number: 13285159
• Product Code: NQR
• UDI-Device Identifier: 00860010683705
• UDI-Public: 00860010683705
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P220014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PRA-PROD-0007
• Device Catalogue Number: CS-2055
• Device Lot Number: PRA-WO-0114
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown