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 Menstrual Irregularities (1959); Scar Tissue (2060); Sepsis (2067); Unspecified Tissue Injury (4559)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 of article:acta clin croat 2020; 59:373-376,doi: 10.20471/acc.2020.59.02.24.  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 products (prolift +m pelvic floor repair, prolene polypropylene mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? patient demographics.There was no patient consequence directly related to the use of absorbable polyfilament polyglactin 910 (1-0 vicryl, ethicon, usa) as it is stated in the article that "after 36 months, the patient was still asymptomatic with no evidence for prolapse recurrence and had regular menstrual cycles".Adverse events associated with prolene polypropylene mesh device reported via mw #2210968-2021-05070.

Event Description

It was reported in a journal article with title: a (b)(6) year-old patient with congenital bladder exstrophy and recurrent pelvic organ prolapse: a case report.A (b)(6) year-old patient was referred to the department with discomfort in perianal region, incomplete voiding, dyspareunia, and apparent genital prolapse.She had a history of congenital be associated with pubic bone agenesis.There was no family history of exstrophy or other congenital anomalies.Her past surgical history was considerable and included multiple reconstructive surgical procedures.The initial surgical procedure was performed 48 hours after birth.The patient underwent complete primary closure of the anterior abdominal wall in the form of bladder preservation while internal diversion of the urine was obtained through a sigmoid reservoir, with satisfactory continence achieved.At the age of 18, suffering from a severe uterine prolapse, the patient underwent transvaginal bilateral sacrospinous hysteropexy using prolift+m system (gynecare/ethicon, somerville, nj, usa).Three years later, severe pop reappeared.Due to complicated surgical history, sacral hysteropexy per laparotomy using prolene mesh (ethicon) was performed.Due to the patient¿s strong fertility desire, considering her extensive surgical history background, approach was to correct pop via the manchester- fothergill procedure (mfp) using an absorbable polyfilament polyglactin 910 (1-0 vicryl, ethicon, usa) suture.Reported complications included severe pop, sepsis, amenorrhea, recurrent prolapse, scars.In conclusion, the management of be has significantly improved in recent decades.This case demonstrates diagnostic challenges and surgical dilemmas in treatment strategy for patients with be and co-existent pop.Furthermore, routine long-term surveillance is necessary in terms of renal function, urinary continence, prolapse recurrence, malignancy, and possible obstetric issues.

• 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
• MDR Report Key: 11899708
• MDR Text Key: 266699013
• Report Number: 2210968-2021-05069
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR