MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 5INX6IN; BARRIER, ABSORBABLE, ADHESION

Model Number 4350XL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Type  Injury  

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.The patient demographic info: age, weight, bmi at the time of index procedure, date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what are the patient comorbidities/concomitant medications? patient symptoms manifestations (location, severity, appearance, systemic or local reaction)? date - time of onset of infection 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? was medical intervention was performed? results? product lot #? is there an alleged product deficiency? if so, what is the alleged deficiency? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?  .

Event Description

It was reported that a patient underwent an unknown ob-gyn surgery on an unknown date and the absorbable barrier was used.It was reported that aseptic peritonitis developed and the relationship to the device is unknown.It was reported that the event occurred around (b)(6) 2021.It was also reported that the patient was relatively young and had no particular problems, but crp level increased after the surgery.The patient recovered and was discharged from the hospital.Additional information was requested.

• Brand Name: GYNECARE INTERCEED 5INX6IN
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-SAN LORENZO; 982 road 183 km 8.3; san lorenzo
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12125852
• MDR Text Key: 265136310
• Report Number: 2210968-2021-06027
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 10705031147843
• UDI-Public: 10705031147843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 4350XL
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2021
• Initial Date FDA Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1