MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 2INX14IN(5.1CMX35.6CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	1951
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Visual Impairment (2138); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Acta neurochir (wien) (1989) 100:70-73.(b)(4).
Event or Problem Description
It was reported via a journal article: the following information is from the journal article.Ito h, onishi h, shoin k, et al.Granuloma caused by oxidized cellulose following craniotomy.Acta neurochir (wien).1989;100(1-2):70-3.A patient ((b)(6) yo) presented with visual impairment 730 days following primary surgery for a ruptured anterior communicating aneurysm, resulting in subarachnoid hemorrhage.The ct scan showed a large granulomatous mass, which was enhanced by contrast medium, and was suspected to be related to the previous aneurysm repair.Surgical removal of the mass showed a granuloma with remnants of oxidized cellulose.During the primary surgery multiple pieces of surgicel were placed at the surgical site and left in the patient.In this case the initial surgery was further complicated by contamination, secondary to the ruptured aneurysm, requiring antibiotics.

• Brand Name: SURGICEL ORIGINAL 2INX14IN(5.1CMX35.6CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10063296
• Report Number: 2210968-2020-03965
• Device Sequence Number: 17030252
• Product Code: LMG
• UDI-Device Identifier: 10705031003019
• UDI-Public: 10705031003019
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2020

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: 1951
• Device Catalogue Number: 1951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/15/2020
• 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: 35 YR