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

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Additional information was requested, and the following was obtained: were the cases discussed in this article previously reported to ethicon?- no.Although the then product manager ((b)(6)) was aware of the study.If yes, please provide a complaint reference number.- na.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? - no.There were no adverse events.The device reduced adhesion not caused them- this was the author's conclusions.Does the surgeon believe there was any deficiency with the ethicon products involved? - no.Citation: http://dx.Doi.Org/10.2147/oas.S41447; open access surgery 2013:6 7¿12.[(b)(4)].

Event Description

Journal article title: maternal morbidity at first repeat cesarean: a sub-analysis of interceed¿ barrier placed at primary cesarean section.The aim of this retrospective study was to evaluate the incidence ad grade of adhesions found at repeat cesarean sections (cs) and the time interval from skin incision to fetal delivery between the barrier with the use of an absorbable adhesion barrier (gynecare interceed¿ absorbable adhesion barrier, gynecare, somerville, nj, usa) and no-barrier groups.During the periods of january 1, 2006 and december 31, 2009, a medical record review of primary and subsequent first repeat cesarean patients were undertaken to determine whether an adhesion barrier would reduce the incidence and/or grade of adhesions found a subsequent repeat cesarean deliveries (cd).A total of 262 primary cesareans were performed, with 43% (n = 112) undergoing repeat cd during the study period.A barrier was used in 53 of these patients, age: 19 to 38 years, at first cd (barrier group) and was not used in 59, age: 18-43 years (no-barrier group).All cases of excessive blood loss had documented lysis of adhesions.In the barrier group, one lysis of grade 2 adhesions was undertaken.There was one (1/53 [1.8%]) case in the barrier group who developed metritis who had given intravenous antibiotic therapy for 48 hours with no sequelae.In conclusion, although limited by the overall sample size, our study serves as a pilot investigation for potential risks and implications of adhesiolysis during repeat cesareans.An increased need for adhesiolysis, resulting in increased in blood loss, was noted in those in whom a barrier had not previously been used.The absence of noted metritis in the barrier group is also reassuring.It is concluded, therefore, that use of an oxidized regenerated cellulose adhesion barrier at primary cs may reduce some aspects of maternal morbidity at subsequent repeat cs.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• 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: 7721402
• MDR Text Key: 115061876
• Report Number: 2210968-2018-74634
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/25/2018
• 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