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 Problem 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: it is understood that the d glucan is a marker and indicator of invasive fungal infections.It is noted that the surgeon does not believe the infection pt experienced is related to the device, provide the following: is there a quality issue? no further information is available.If the surgeon does not believe the infection treated with antibiotics is related to the interceed, what is the etiology of the infection? no further information is available.Is the surgeon making a correlation between the ""high"" d glucan and the interceed? the surgeon commented that it is supposed that cell walls existing in cellulose in the interceed affected measured value of d glucan.Please define ""high"" value and provide the labs normal reference range? no further information is available.What was the procedure being performed? no further information is available.Device lot number (only the actual lot of the device used)? the lot number is unknown.No further information will be provided.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the absorbable adhesion barrier was used.It was also reported after the surgery, the patient experienced infection and antibiotics were administered but measured value of d glucan remained high.The surgeon opined that there is no causal relationship between the infection and the absorbable adhesion barrier.The surgeon opined it is supposed that cell walls existing in cellulose in the absorbable adhesion barrier affected measured value of d glucan.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 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8974694
• MDR Text Key: 156920792
• Report Number: 2210968-2019-86742
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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: 08/22/2019
• 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): Required Intervention