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

Model Number 1951

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Visual Impairment (2138); Not Applicable (3189)

Event Type  Injury  

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 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)
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10063296
• MDR Text Key: 191268304
• Report Number: 2210968-2020-03965
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003019
• UDI-Public: 10705031003019
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1951
• Device Catalogue Number: 1951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/15/2020
• 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: 35 YR