MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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, 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.(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 cite: doi: 10.19613/j.Cnki.1671-3141.2017.72.035.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 ethicon product (artisyn y-shaped mesh, prolift, tvt-obturator) 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 the ethicon products involved? patient demographics? events associated with artisyn y-shaped mesh reported via mw # 2210968-2022-07422.Events associated with prolift reported via mw # this report.Events associated with tvt-obturator reported via mw # 2210968-2022-07424.

Event Description

It was reported in a journal article with title: laparoscopic colpopexy/uterosacral fixation versus modified total pelvic reconstruction for pelvic defects.The aim of the study is to compare the clinical effects of laparoscopic colpopexy/uterosacral fixation and modified total pelvic reconstruction in the treatment of pelvic defects.The clinical data of 62 patients with pelvic defect prolapse treated in the department of gynecology, liuzhou maternity and child health care hospital were analyzed retrospectively.The experimental group (n = 37) was treated with laparoscopic vaginal/uterosacral fixation, and the comparison group (n = 25) was treated with modified total pelvic floor reconstruction.The experimental group was treated with laparoscopic vaginal/uterosacral fixation for surgical treatment, specifically: using a y-shaped mesh manufactured by johnson & johnson, the surgical procedures were performed in strict order, and prolift mesh (ethicon) was selected for the surgical mesh.Cervical resection was performed in patients with cervical lengthening, and transvaginal tension-free sling (tvt-o) ethicon was also performed in patients with stress urinary incontinence.Reported complications included symptomatic prolapse recurrence (n=3) , mesh contracture (n=3), posterior wall prolapse recurrence (n=1), anterior wall prolapse recurrence (n=1) , mesh exposure (n=1), constipation (n=4) , urinary incontinence, (n=3), dyspareunia.In conclusion compared with modified total pelvic floor function reconstruction, laparoscopic vaginal/uterosacral fixation in the treatment of pelvic defects has the advantages of less intraoperative blood loss, less postoperative complications, higher postoperative subjective satisfaction and sexual life quality, with good efficacy.It is worthy of being actively promoted in clinical practice.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• 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: 15403035
• MDR Text Key: 299706868
• Report Number: 2210968-2022-07423
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2022
• 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
• Patient Sex: Female