MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL DURA-GUARD; DURA SUBSTITUTE

Catalog Number	DG0814SN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Unspecified Infection (1930); Inflammation (1932)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
A patient experienced headaches, inflammation and an unspecified infection after undergoing a surgery for chiari malformation in which dura-guard was placed suboccipitally.It was reported the patient experienced surgical pain and headaches the day after the surgery.Approximately two months later, the patient was still experiencing headaches and a month later the patient presented to the emergency room with headaches.Approximately four months after the surgery, the patient experienced pressure due to a large fluid collection in the area of the implant.Approximately 133 days after the initial surgery, the patient underwent a surgery due to an inflammatory response from the dura-guard; subsequently the dura-guard was removed.On an unreported date during hospitalization, the patient received vancomycin via a peripherally inserted central catheter (picc) for an unspecified infection (no further details).On an unreported date, the patient was discharged with the picc line to continue antibiotic treatment at home.At the time of this report, the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information : upon follow up it was reported upon reoperation, adhesions were found between the dura-guard and the brain.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: DURA-GUARD
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): BAXTER HEALTHCARE - SAINT PAUL; saint paul MN
• MDR Report Key: 8436720
• Report Number: 1416980-2019-01495
• Device Sequence Number: 2242340
• Product Code: GXQ
• UDI-Device Identifier: 00085412531007
• UDI-Public: (01)00085412531007
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K982282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2019

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 Expiration Date: 07/17/2022
• Device Catalogue Number: DG0814SN
• Device Lot Number: SP17L01-1261416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 05/21/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/18/2019; 05/24/2019
• 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
• Patient Age: 40 YR
• Patient Weight: 82