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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Scar Tissue (2060); No Code Available (3191)

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.Citation: surg laparosc endosc percutan tech.2012; volume 22(1).[(b)(4)].

Event Description

Title : comparison between endoscope-assisted partial mastectomy with filling of dead space using absorbable mesh and conventional conservative method on cosmetic outcome in patients with stage i or ii breast cancermy.Studies comparing cosmetic outcome between conventional conservative method (ccm) and endoscope-assisted partial mastectomy (eapm) are scarce.A total of 111 patients with stage i or ii breast cancer who underwent ccm (51 patients; age: 11.4 years; bmi: 20.1 to 25.6) or eapm (60 patients; age: 12.5 years; bmi: 20.2 to 25.2) were reviewed and included in the study.During the ccm procedure, the surgical wound was closed by placing vicryl 3-0 subcutaneous sutures (ethicon).During the eapm procedure, vicryl mesh (ethicon) wrapped in interseed (ethicon) was used to fill the dead space.The number of meshes depended on the resection volume.The authors filled the mesh loosely until the operative-side breast was not dented in the supine position, and symmetry of both breasts was achieved.The surgical wound was closed by placing subcutaneous buried sutures using pds ii 5-0 clear (ethicon) and dermabond (ethicon).In the ccm group, reported complications included nipple deviation (n-26), breast atrophy (n-15), skin change (n-17), and scar (n-16).In the eapm group, reported complications included nipple deviation (n-35), breast atrophy (n-33), skin change (n-29), scar (n-33), and mesh infection (n-7).Eapm is superior to ccm for postoperative cosmetic outcome, in particular, with respect to atrophy and scar.Generally, a lower tumor location is associated with postoperative cosmetic outcome difficulties in bct, but in the study eapm significantly improved cosmetic outcome in location b compared with ccm.Studies with larger sample size are warranted to verify the findings in regards to its performance on tumor location.Prevention of mesh infection may further improve cosmetic outcome.

Manufacturer Narrative

Corrected h-6 patient codes: 1930, 3191- atrophy.

• 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
• MDR Report Key: 9579350
• MDR Text Key: 189449570
• Report Number: 2210968-2020-00275
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

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: 12/16/2019
• Initial Date FDA Received: 01/11/2020
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 01/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention