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 Adhesion(s) (1695); Fever (1858); Menstrual Irregularities (1959); Uterine Perforation (2121); Discomfort (2330)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) device not returned.  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.  please see article attached.  attempts are being 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.  were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon product (interceed) involved caused and/or contributed to the postoperative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (interceed) used in this procedure? patient demographics?.

Event Description

It was reported in a journal article with title: the pregnancy outcomes of the women with severe intrauterine adhesion adhesectomy after postoperative placement of anti-adhesive membrane or water-filled balloon.Abstract objective: to analyze the effect of the anti-adhesive membrane or water injection balloon placement on the pregnancy outcomes of women after severe intrauterine adhesectomy.Methods: the clinical data of 104 women with severe intrauterine adhesions who had undergone hysteroscopic intrauterine adhesectomy from august 2017 to august 2018 was analyzed retrospectively.According to the different postoperative treatment methods, these women were divided in group a (32women with postoperative intrauterine device (iud) inserted) were in, group b (35women with postoperative anti-adhesion membrane inserted),and group c (37women with postoperative water-filled balloon inserted).The clinical efficacy, the recovery situation of uterine morphology, the incidence of complications, and the pregnant situation within postoperative 2 years of the women were compared among the three groups.Results: the total effective rate and the delivery rate within postoperative 2years of the women in group b were 94.3%and 76.5%, and those of the women in group c were 89.2%and 72.2%,which were all significant higher than those(65.6% and 41.7%)of the women in group a(all p<0.05).The incidence of complications and the postoperative intrauterine adhesion scores of the women in group a were 37.5%and 9.1±1.5points,which were all significant higher than those (11.4%,4.3±1.1points)of the women in group c and those (16.2% and 4.7±1.2points)of the women in group b (all p<0.05).There were no significant differences in total effective rate, the delivery rate within postoperative 2 years, the intrauterine adhesion score, and the complication rate of the women between group b and group c (p>0.05).The age of the antiadhesion group was (27.5 ± 3.3) years old (22 ~ 34) years old, bmi was (22.3 ± 1.5) kg /m 2 (18.8 ~ 24.9) kg/m 2, 29 cases of hypomenorrhea and 6 cases of secondary amenorrhea.As such, the events cannot be completely ruled out as a complaint.Patient experienced lower abdominal distension discomfort, low fever, uterine perforation and other complications.As such, events cannot be completely ruled out as a complaint.Most of the patients in group b showed central adhesions or iud was encircled by new adhesive bands.As such, the events cannot be completely ruled out as a complaint.Conclusion: the placement of anti-adhesive membrane or water injection balloon of women after severe intrauterine adhesions surgical can improve their menstrual situation, and can effectively prevent intrauterine re-adhesion, can increase the postoperative pregnancy rate and delivery rate, and help to improve their pregnancy outcomes.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 07/30/2021.The following information was requested, but unavailable: were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon product (interceed) involved caused and/or contributed to the postoperative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (interceed) used in this procedure? patient demographics? 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, 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.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11962740
• MDR Text Key: 263491129
• Report Number: 2210968-2021-05366
• 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: 05/10/2021

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: 05/10/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 07/11/2021
• Supplement Dates FDA Received: 07/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention