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); 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.

Event Description

It was reported via a journal article: the following information is from the journal article attached.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) received a follow up ct scan 540 days following removal of a meningioma, which appeared as a space-occupying lesion, suspected to be a large granuloma.The patients follow up ct scan was interpreted as a possible recurrence of the excised meningioma in the form of a mass in fronto-polar region.A second procedure was performed, and the removed tissue revealed a granuloma with remnants of oxidized cellulose.Surgicel was left at the surgical site during initial procedure.

• 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: 10063297
• MDR Text Key: 196921656
• Report Number: 2210968-2020-03964
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR