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

Catalog Number 4350

Device Problems Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Inflammation (1932); Pain (1994); Vomiting (2144); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.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 a patient underwent a right hemicolectomy surgery on (b)(6) 2015 for ascending colon cancer stage i and an absorbable adhesion barrier was used.The patient experienced an adherent small-intestinal obstruction on (b)(6) 2015 and was hospitalized.Liquid level of small intestine of ectasia was confirmed by x-ray.On (b)(6) 2015, emesis was confirmed so the patient began to fast and a stomach tube was inserted.The patient's condition was considered well on (b)(6) 2015.The patient experienced a secondary event of a surgical site infection in the superficial part of the incision in (b)(6) 2015.The patient had pain and tenderness at the incision.Inflammation, tumefaction and hot-flash were reported.Only treatment at the bed side was performed.The patient's condition got well on (b)(6) 2015 for this issue.It was reported that there was a possibility of temporal intestinal tract paralysis.The surgeon opined the absorbable adhesion barrier was not related to the adherent small intestinal obstruction.The patient was discharged on (b)(6) 2015.The current condition of the patient was reported as recovered.

Manufacturer Narrative

It was reported that a patient underwent a right hemicolectomy surgery on (b)(6) 2015 for ascending colon cancer stage i and an absorbable adhesion barrier was used.The patient experienced temporary paralysis of the intestine on (b)(6) 2015 and was hospitalized.Liquid level of small intestine of ectasia was confirmed by x-ray.On (b)(6) 2015, emesis was confirmed so the patient began to fast and a stomach tube was inserted.The patient¿s condition was considered well on (b)(6) 2015.The patient experienced a secondary event of a surgical site infection in the superficial part of the incision in (b)(6) 2015.The patient had pain and tenderness at the incision.Inflammation, tumefaction and hot-flash were reported.Only treatment at the bed side was performed.The patient¿s condition got well on (b)(6) 2015 for this issue.The surgeon opined the absorbable adhesion barrier was not related to the temporary paralysis of the intestine.The patient was discharged on (b)(6) 2015.The current condition of the patient was reported as recovered.(b)(4).

• 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 00754
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5393555
• MDR Text Key: 36898825
• Report Number: 2210968-2016-02943
• 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,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 4350
• Device Lot Number: JGB5262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 65