MAUDE Adverse Event Report: ETHICON INC. PROLIFT +M 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); Unspecified Infection (1930)

Event Date 02/15/2022

Event Type  Injury  

Event Description

Title: postoperative indications for further surgery following post-transvaginal prolifttm mesh repair after a two-year follow-up period: a single-centre study for pelvic organ prolapse: a comparative study.The objective of this study is to investigated the frequency of further surgery post-artificial mesh (prolift pelvic floor repair system; ethicon) repair of pelvic organ prolapse.In total, 257 patients who underwent prolift repair were evaluated for further surgery frequency, clinical outcomes, and demographic characteristics.Reported complications included mesh exposure (n=7), mesh infection (n=1), stress urinary incontinence (n=24), de novo stress urinary incontinence (n=6), persistent stress urinary incontinence (n=18) recurrent prolapse (n=6).In conclusion 14.7% participants required fs after prolift repair, commonly to treat sui.Fs for mesh exposure and recurrent prolapse was considerably limited.Surgeons should be aware of the requirement for long-term follow-up and train their surgical technique for performing prolift repair.Further studies are required to corroborate our outcomes for long-term follow-up.

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.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.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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: journal of obstetrics and gynaecology, 42:6, 2115-2120, doi: 10.1080/01443615.2022.2033184.

• Brand Name: PROLIFT +M 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: 15976124
• MDR Text Key: 305421175
• Report Number: 2210968-2022-10238
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2022

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: 12/07/2022
• Initial Date FDA Received: 12/14/2022
• 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