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 Problems Abscess (1690); Fever (1858); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)

Event Date 11/15/2019

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: was the surgery performed as a treatment of the abscess? or did the patients clinical presentation result in the surgeon doing an exploratory laparotomy to determine if a intestinal /bowel perforation was present and a result of an intraoperative surgery related issue? the surgeon suspected intestinal perforation, reoperation was performed.Did the surgeon diagnosis a intestinal bowel perforation ¿ yes or no? no further information is available.If yes to bowel perforation was confirmed, what was the cause of it, tell us if the perforation was a result of the device interceed or an intraoperative surgical related event? does the surgeon believe that the abscess was a result of the interceed? if not, what does the surgeon believe the etiology of the abscess was? the surgeon commented that there is a possibility of the interceed causing the event due to the following reasons.The abscess was confirmed on the area where the interceed had been placed.Enterobacter was detected.The crp level dropped even after the interceed was removed.During operation it was noted that cleaning was performed, please explain did the surgeon drain the abscess during the exploratory lap.Or was the abdominal cavity flushed so surgeon could to exploratory procedure to determine if bowel perforation occurred? =>no further information is available.It was reported enterobacter was detected, did the patient have an infection? was this determined during the exploratory lap and was a culture performed to dx this? no further information is available.Is the surgeon indicating that the enterobacter was caused by the interceed? if not what is the suspected etiology of the enterobacter? there is a possibility of the interceed causing the event, but the surgeon thought the patient¿s problem might be related to the event.There is a chance that the patient might be easily infected due to the medical history.It was noted that patients history included chemotherapy for 3 years.Please tell us when the patient received chemotherapy and for what specific reason (ie type and location of cancer)? no further information is available.Was the patient immunocompromised when the patient underwent surgery for gallbladder removal? no further information is available.How is the patient doing at this time? no further information is available.Provide patient demographics, it was reported patient was a female.Please provide: date of birth? no further information is available.Age? no further information is available.Weight & bmi? no further information is available.Device lot number? the lot number is unknown.

Event Description

It was reported that the patient underwent a cholecystectomy procedure on (b)(6) 2019 and the absorbable adhesive barrier was applied under the abdominal wall.On (b)(6) 2019, the patient developed pain and fever.The c-reactive protein level became 32.Since the surgeon suspected intestinal perforation, the reoperation was performed.During the reoperation, abscess was confirmed on the area where the absorbable adhesive barrier had been placed.The absorbable adhesive barrier was removed, and cleaning was performed.Then, a drain was placed, and the reoperation was completed.It was also detected enterobacter.The crp level became 12 at the beginning of the following week and on (b)(6) 2019 it went down to 3.The patient was discharged from the hospital by (b)(6) 2019.The surgeon opined that the patient¿s factors might be related to the event as there is a chance that the patient might be easily infected due to her medical history.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; san lorenzo PR ; *
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9739069
• MDR Text Key: 190311998
• Report Number: 2210968-2020-01364
• 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: 02/16/2020

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: 02/16/2020
• Initial Date FDA Received: 02/21/2020
• 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