MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW 2INX4IN(5.1CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	2082
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pneumonia (2011)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? the diagnosis and indication for the index surgical procedure? relevant patient history? any concurrent use of other products? what was the intended use of the surgicel? where was the surgicel used (on what tissue)? how much surgicel was used during the procedure? was the surgicel product left in place? was the excess irrigated and removed? what were current symptoms following the index surgical procedure? onset date? what is physician¿s opinion as to the etiology of or contributing factors to this event? was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative fever and pneumonitis? what is the patient¿s current status? if applicable, will product be returned, return date, tracking information? what was the drug therapy used for the patient¿s fever and pneumonitis? has any other surgical or medical intervention been performed? 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a radical total gastrectomy procedure on (b)(6) 2020 and absorbable hemostat was used.The patient suffered from fever 7 days after using the product.Chest ct showed that there was pneumonitis.Anti-infection and antipyretic symptomatic treatment were given.Additional information was requested.

• Brand Name: SURGICEL SNOW 2INX4IN(5.1CMX10.2CM)
• 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: 10140475
• Report Number: 2210968-2020-04419
• Device Sequence Number: 16708315
• Product Code: LMG
• UDI-Device Identifier: 10705031063594
• UDI-Public: 10705031063594
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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 Expiration Date: 07/31/2021
• Device Model Number: 2082
• Device Catalogue Number: 2082
• Device Lot Number: PJE0091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/10/2020
• 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: 82 YR