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	Pleural Effusion (2010); Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? patient demographics: initials/ id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions).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.Shinshu med j 68 : 49 53, 2020.(b)(4).
Event or Problem Description
It was reported via a journal article: a (b)(6)-year-old woman was referred to our institution because of suspected of lung cancer due to a part- solid-nodule in her right lower lobe, and received thoracoscopic wedge resection.An oxidized cellulose absorbable hemostatic agent was attached to the wound surface.Furthermore, fibrin glue was applied for reinforcement.Postoperative oral intake was started on the first postoperative day (pod) ; however, the drainage turned white on the 2nd pod.We diagnosed this as postoperative chylothorax, and octreotide and a low-fat-diet therapy were started.A chest computed tomography (ct) showed pleural effusion on the left side on the 6th pod, so thoracentesis of the left side was performed and diagnosed as bilateral chylothorax.Conservative management decreased the chylous leakage, and chylothorax did not recur after evaluation of the chest drain.The pathological diagnosis was adenocarcinoma (ptisn0m0 stage 0), and the patient has been recurrence-free for 3 years postoperatively.Chylothorax following thoracoscopic wedge resection is an extremely rare occurrence.Shinshu med j 68 : 49 53, 2020 (received for publication july 4, 2019 ; accepted in revised form september 2, 2019).
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and the following was obtained: -were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.=>no.This is our first report to you.-does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? =>no information and no further information is available.-does the surgeon believe there was any deficiency with the ethicon products used in this procedure? =>he did not mention that there was defective with our products.-patient demographics: initials/ id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) =>age 79, female.She had history of atrial fibrillation.- can you identify the product code of the biologic individual box? =>there is no information about product code and no further information is available.- can you identify the lot number of the biologic individual box? =>no further information is available.- will the biologics and the application device be returned for evaluation? =>no sample will be returned.- what was the date of the procedure? =>no further information is available.- what was the indication for using the product? =>no further information is available.- was there any patient consequence? =>the patient diagnosed as postoperative chylothorax.- can specific patient demographics initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? =>age 79, female.She had history of atrial fibrillation.- what is the surgeon¿s opinion as to the relationship of the product to the symptoms? =>no further information is available.- was medical intervention indicated to treat the symptoms? if so, what was the medical intervention required? =>octreotide and a low-fat-diet therapy were started.- what is the current condition of the patient? =>the patient was discharged from the hospital.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 10113782
• Report Number: 2210968-2020-04299
• Device Sequence Number: 2115452
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR