MAUDE Adverse Event Report: ETHICON INC. SURGICEL NU-KNIT 6INX9IN(15.2CMX22.9CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1946
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure? no further information is available.Date of index surgical procedure? no further information is available.The diagnosis and indication for the index surgical procedure? pancreaticoduodenectomy.Relevant patient history? no further information is available.Any concurrent use of other products? no further information is available.Where was the surgicel used (on what tissue)? in the abdominal cavity.How much surgicel was used during the procedure? no further information is available.Was the surgicel product left in place? the surgeon said the surgicel nu-knit was left in the abdominal cavity as it was for hemostasis, but detailed information is not available.What were current symptoms following the index surgical procedure? onset date? no further information is available.Were cultures performed? if yes, results? no further information is available.Has any surgical or medical intervention been performed? no further information is available.What is physician¿s opinion as to the etiology of or contributing factors to this event? no further information is available.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative infection? no further information is available.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent a pancreaticoduodenectomy procedure on an unknown date and an absorbable hemostat was used.The patient experienced and infection.It is unknown how the absorbable hemostat was used.It was left in the abdominal cavity as it was for hemostasis during wound closure because the device would be absorbed.The patient was discharged from the hospital.The event was not serious.Further details were not provided from the hospital.Additional information was requested.

• Brand Name: SURGICEL NU-KNIT 6INX9IN(15.2CMX22.9CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8911253
• Report Number: 2210968-2019-85826
• Device Sequence Number: 11247272
• Product Code: LMG
• UDI-Device Identifier: 10705031002999
• UDI-Public: 10705031002999
• 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
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 1946
• Device Lot Number: MPE3431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention