MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 3INX4IN; BARRIER, ABSORBABLE, ADHESION

Model Number	4350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fever (1858); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #:(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(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 date and name of initial surgical procedure the diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications date - time of onset of abscess and fever from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? what was the results of the laparotomy and irrigation/ medical intervention that was performed? product lot #.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
Event or Problem Description
It was reported that a patient underwent a laparoscopic distal gastrectomy on (b)(6) 2021 and the absorbable adhesion barrier was used.It was reported that the adhesion barrier was used just below the abdominal wall.It was reported that after the surgery the patient developed a low-grade fever.It was reported that a ct scan was performed that revealed an abscess.It was reported that after the surgery, the abscess was treated with puncture, but it injured the intestine, so the patient was treated by laparotomy and irrigation.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 01/31/2022.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 inc., 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.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure : unknown.Date and name of initial surgical procedure : procedure name is laparoscopic distal gastrectomy.Procedure date is (b)(6) 2021.The diagnosis and indication for the initial surgical procedure? : unknown.Other relevant patient history/concomitant medications : unknown.Date - time of onset of abscess and fever from the surgical procedure? : unknown.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? : unknown.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? : no.Were cultures performed? results? : unknown.What was the results of the laparotomy and irrigation/ medical intervention that was performed? : unknown.Product lot # : unknown.What is physician¿s opinion as to the etiology of or contributing factors to this event? : unknown.What is the patient's current status? : unknown.

• Brand Name: GYNECARE INTERCEED 3INX4IN
• Common Device Name: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12922630
• Report Number: 2210968-2021-12313
• Device Sequence Number: 14887312
• Product Code: MCN
• UDI-Device Identifier: 10705031005396
• UDI-Public: 10705031005396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P880047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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 Model Number: 4350
• Device Catalogue Number: 4350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown