MAUDE Adverse Event Report: NATUS NEURO INCORPORATED DURAFORM; DURAFORM PRODUCT

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reference literature article "reactive gliosis mimicking tumor recurrence - a case series documenting mri abnormalities and neuropathological correlates", by hugh kearney, et al.Event required additional intervention for diagnostic confirmation.Three attempts made to reach out to doctor to determine if a natus device was involved.No response received from doctor.

Event Description

Medical literature article documents suspicion of tumor recurrence post resection after use of a duraform device.Duraform manufacturer not identified.

• Brand Name: DURAFORM
• Type of Device: DURAFORM PRODUCT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: janessa boone ; 5955 pacific center boulevard; san diego, CA 92121 ; 6088298603
• MDR Report Key: 8739221
• MDR Text Key: 149345057
• Report Number: 3010611950-2019-00038
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR