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

Catalog Number 4350XL

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Not Applicable (3189)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 12/12/2019 (b)(4).To date the device has not been returned.If the device or further details are received at the 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.What procedure was performed, indication and what was approach (open, laparoscopic or other)? an unknown gastric surgery.Other relevant patient¿s medical history/comorbidities? no further information is available.What other concomitant implanted products were used.No further information is available.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no further information is available.Did the patient receive any prophylactic antibiotics pre- or intra-operation? no further information is available.Location of abscess and infection? no further information is available.Was the culture of the infection performed? if yes, results? no further information is available.When and where did the bleeding occur? no further information is available.The source and triggering event of bleeding and pancreatic fluid leakage? the surgeon's comment is following.I don't think the product is bad, but the patient also had bleeding and pancreatic fluid leaks, so an abscess occurred, reacting with the product as a foreign body and causing adverse event.What is the patient's current status? the patient is now stable but is still hospitalized and continues to wash as of (b)(6) 2019.No further information will be provided.

Event Description

It was reported that the patient underwent an unknown gastric surgery on (b)(6) 2019 and the absorbable adhesive barrier was placed directly under the abdominal wall.One month and 3 days after the surgery, the fever did not go down, so an abscess was observed when ct was taken.The drainage was performed to remove the abscess.Then, material like the device was drained.The surgeon opined that the absorbable adhesive barrier might have caused the infection.The surgeon opined that the device is not bad, but the patient also had bleeding and pancreatic fluid leaks, so an abscess occurred, reacting with the product as a foreign body and causing adverse event.The patient is now stable but is still hospitalized and continues to wash as of (b)(6) 2019.No further information is available.

• Brand Name: GYNECARE INTERCEED 5INX6IN
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9461487
• MDR Text Key: 182990006
• Report Number: 2210968-2019-90853
• 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: 11/20/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/12/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention