MAUDE Adverse Event Report: ETHICON INC. INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER; BARRIER, ABSORBABLE, ADHESION

Catalog Number 4350XL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fever (1858); Inflammation (1932); Pain (1994); No Code Available (3191)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a laparoscopic colectomy on (b)(6)2017 and an absorbable adhesion barrier was used.The patient experienced accumulation of liquid and gas, fever and abdominal pain.The accumulation of liquid was confirmed by ct.The shape of the accumulation area was a rectangle, which was the same shape with the adhesion barrier.The patient experienced the fever on (b)(6)2017 and was provided oral antibiotics.Inflammation was relieved and the level of crp became decreased.The surgeon opined that it is unknown whether there was a causal relationship between the absorbable adhesion barrier and the reported event.Additional information has been requested.

Manufacturer Narrative

Additional information additional patient codes: (b)(4)- treatment with medication corrected device codes: (b)(4)- inflammation occurred additional information was requested and the following was obtained: [current stats of patient] the patient has already discharged from the hospital.- from (b)(6) 2017 (pod 4) to (b)(6), levofloxacin was applied to the patient.- on (b)(6) (pod 11) the patient was discharged from the hospital.- on (b)(6), the patient visited the hospital as an outpatient.It was observed that the caudal side on the umbilical area was hard.The patient had a slight pain there.No symptom of infection was seen.[treatment plan] the patient will be monitored.Diagnostic imaging is not scheduled.[surgeon¿s opinion about seriousness and reason] not serious (moderate/ minor) since surgical treatment is not necessary at this moment.[surgeon¿s comment] there is a possibility that the accumulation of liquid was caused by the interceed.Since there was no accumulation of liquid around the sutured area, the problem was not due to the surgeon¿s technique of suturing.

• 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): UNKNOWN; unknown; x
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6768051
• MDR Text Key: 81847120
• Report Number: 2210968-2017-33336
• Device Sequence Number: 1
• Product Code: MCN
• 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,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 4350XL
• Device Lot Number: LCB3401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2017
• 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
• Patient Age: 82 YR
• Patient Weight: 60