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); Pain (1994); Unspecified Tissue Injury (4559)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.An attempt has been made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: j obstet gynaecol can 2022;44(8):926-930.Https://doi.Org/10.1016/j.Jogc.2022.03.018.

Event Description

Title: sexual and psychosocial outcome after neo vaginoplasty using interceed in females with mayer-rokitanskyküster-hauser syndrome: a case control study.The purpose of this study was to compare anatomical and psychosexual outcomes between women with mayer-rokitansky-küster-hauser (mrkh) syndrome who had undergone vaginoplasty and age-matched, sexually active, childless women.All females who were diagnosed with mrkhs and underwent modified mcindoe vaginoplasty from february 2018 to may 2021 at our center were included in the study.The mkrh group consisted of 21 patients with mean age of 21 y.O ¿ 25 years old.During the procedure they use interceed (johnson and johnson) in covering the mold.This mold was created preoperatively using a condom stuffed with foam rolled over 5 ml syringe with an interceed stitched over it.The mold was replaced with dental cake mold after a week.The reported complications included an infection (n=2), treatment: antibiotics, rectal injury (n=1), treatment: reoperation, vaginal stenosis (n=1), treatment: recreation of vagina and dyspareunia (n=4), treatment: not mentioned in conclusion, the findings of this study suggest that psychosocial and sexual function of patients with mrkhs is comparable to that of the general population following neovaginoplasty.Creation of a spacious vagina adequate for sexual function results in an overcompensated feeling of psychosexual satisfaction.However, future studies focusing on pre- and post evaluation of psychosexual outcome after neovaginoplasty are required to elucidate the actual outcome of vaginoplasty in these patients.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17835558
• MDR Text Key: 324497924
• Report Number: 2210968-2023-07114
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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: 09/01/2023
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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