MAUDE Adverse Event Report: NATUS NEURO INCORPORATED; DURAFORM 4X5 SPONGE SINGLE

Model Number	801480
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Meningitis (2389)
Date of Event	12/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Second surgery was done to clean the implant site.Implant will remain in patient; therefore, no further investigation possible.
Event or Problem Description
After a procedure involving duraform, patient developed meningitis.A second surgery was done to clean the implant site.

• Common Device Name: DURAFORM 4X5 SPONGE SINGLE
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8418319
• Report Number: 3010611950-2019-00015
• Device Sequence Number: 19294391
• Product Code: GXQ
• UDI-Device Identifier: 10886704036746
• UDI-Public: 10886704036746
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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 Model Number: 801480
• Device Catalogue Number: 801480
• Device Lot Number: CT005501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention