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

Catalog Number	1951
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? was the picc line inserted on (b)(6) 2019? the diagnosis and indication for the picc line? relevant patient history? any concurrent use of other products? lot # of the surgicel? where was the surgicel used (on what tissue)? how much surgicel was used during the procedure? what were current symptoms following the picc line procedure? onset date? what was the cause of death? what was the date of death? has any surgical or medical intervention been performed besides removing the wadded up surgicel? what is physician¿s opinion as to the etiology of or contributing factors to these events? was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative events?.
Event or Problem Description
It was reported that a patient underwent an unknown vascular procedure on (b)(6) 2019 and after the procedure, the patient needed a picc line installed.The nurse was inserting the picc line and there was bleeding.The nurse couldn't stop the bleeding and used an absorbable hemostat to stop the bleeding by packing/wadding up the absorbable hemostat under the skin.The patient was still in the hospital for two days and it was noticed that the absorbable hemostat was wadded up under the patient's skin and couldn't easily be removed.A hospital doctor surgically removed the absorbable hemostat and closed the incision.The patient continued to stay in the hospital for observation and expired due to other complications not related to the absorbable hemostat, according to the hospital.Additional information was requested.

• 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: 9354934
• Report Number: 2210968-2019-90171
• Device Sequence Number: 2402782
• Product Code: LMG
• UDI-Device Identifier: 10705031003019
• UDI-Public: 10705031003019
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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 Catalogue Number: 1951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention