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)

Event Type  Injury  

Manufacturer Narrative

(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: during a small intestine resection due to crohn's disease, the interceed was placed in the pelvis.About 1 week after the operation, infection occurred.Abscess occurred along the area where the interceed had been placed.Drainage to prevent infection was ongoing when the event occurred.Hospitalization period was extended but the patient was recovered and has been already discharged.The patient demographic info: age, gender, weight, bmi at the time of index procedure: no further information is available.Date and name of initial surgical procedure? the procedure is small intestine resection.The date is unknown.The diagnosis and indication for the initial surgical procedure? crohn's disease.Where was interceed used/applied, what part/tissue/organ? the interceed was placed in the pelvis.Other relevant patient comorbidities? no further information is available.Other concurrently implanted devices? no further information is available.Date - time of onset of infection from the surgical procedure? about 1 week after the operation.Location, severity and appearance of infection? abscess occurred along the area where the interceed had been placed.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-, intra- or post-operation? no further information is available.Were cultures performed? results? no further information is available.What medical intervention was performed? results? no further information is available.Product lot number? the lot number is unknown.What is physician¿s opinion as to the etiology of or contributing factors to this event (infection) ? no further information is available.What is the patient's current status? hospitalization period was extended but the patient was recovered and has been already discharged.No further information will be provided.

Event Description

It was reported that the patient underwent a small intestine/bowel resection on unknown date and the absorbable adhesion barrier was placed in the pelvis.About one week after the surgery, infection occurred.Abscess occurred along the area where the absorbable adhesion barrier had been placed.The drainage to prevent infection was ongoing when the event occurred.Hospitalization period was extended but the patient was recovered and has been already discharged.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: 9485459
• MDR Text Key: 174519400
• Report Number: 2210968-2019-91024
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• 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
• Date Manufacturer Received: 11/26/2019
• 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