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

Catalog Number 4350XL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Peritonitis (2252); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Date sent to the fda: 11/15/2017.(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: name of initial surgical procedure? colectomy.The diagnosis and indication for the initial surgical procedure? 3 days after the initial operation, the crp value increased, and inflammatory reaction was confirmed.The result of ct image showed that there was ascites fluid under the right douglas' pouch.Therefore an urgent open surgery was performed due to the suspicion of the perforation.What were current symptoms following the index surgical procedure? onset date? reoperation date was unknown.Other relevant patient history/concomitant medications: no information.What were the signs and symptoms that made that instigated the diagnosis of peritonitis? the crp value increased, and inflammatory reaction was confirmed.The result of ct image showed that there was ascites fluid under the right douglas' pouch.What other conditions were found at time of surgery that made the physician believe the interceed was the cause? during the reoperation, the following situation was observed; the interceed just under the peritoneum had dissolved, and it had become gelatinous.Many abscesses had adhered to the interceed.Inflammation was observed on the peritoneum around the interceed.Results of reoperation? the interceed was removed, and the affected site was cleaned.Was the interceed removed? yes.What is the patient's current status? as of (b)(6), the patient is getting well.

Event Description

It was reported that the patient underwent an open surgery of colon resection/colectomy procedure on (b)(6) 2017 and the absorbable adhesive barrier was placed under the peritoneum.During (b)(6), there were no specific issues observed.On (b)(6) 2017, the crp value increased, and inflammatory reaction was confirmed.The result of ct image showed that there was ascites fluid under the right douglas' pouch.It was also reported that the patient experienced peritonitis after the procedure.The patient underwent an urgent open surgery due to suspicion of the perforation.During the surgery, the following situation was observed: the absorbable adhesion barrier had dissolved just under the peritoneum, and it had become gelatinous.Many abscesses had adhered to the absorbable adhesion barrier.Inflammation was also observed on the peritoneum around the device.There was no leakage observed in the abdominal cavity.It was found that the color of the device had become brown.The absorbable adhesion barrier was removed and the affected site was cleaned.Then, the surgical wound was closed.The surgeon opined that the device contributed to the infection.The surgeon suspected that infection occurred because the absorbable adhesion barrier had become the culture medium of the infection.The patient is currently in the hospital and, as of (b)(6) 2017, the patient is getting well by taking antibiotics.

• Brand Name: GYNECARE INTERCEED
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7035665
• MDR Text Key: 92157136
• Report Number: 2210968-2017-71263
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• 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: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• 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: 10/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention