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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Fever (1858); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

(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.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the 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 products 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 used in this procedure? citation: the journal of obstetrics and gynecology of india.2013; 63(5): 328 331.Doi: 10.1007/s13224-013-0396-0.(b)(4).

Event Description

It was reported via journal article: ¿title: perioperative complications in vaginal mesh procedures using trocar in pelvic organ prolapse repair¿ author : demirci fuat , birgul karakoc , demirci oya , demirci elif, akman yavuz, karaalp erhan, dolgun nihal citation: the journal of obstetrics and gynecology of india.2013; 63(5): 328 331.Doi: 10.1007/s13224-013-0396-0.The aim of this retrospective study was to document intraoperative and early post-operative complications associated with the use of vaginal mesh with trocar in pelvic organ prolapse (pop) repair.A total of 120 patients underwent vaginal repair of pop using vaginal mesh with trocars and were included in the study.Of which, 31 patients underwent anterior mesh repair (light mesh 10, avaulta 1, perigee 1, and prolift 19); 35 patients underwent posterior mesh repair (light mesh 2, posterior ivs 17, and prolift 16); and 54 patients underwent anterior and posterior mesh repair (light mesh 8, prolift 32, and prolift m 14).During the surgical procedure, a midline incision was made, which included full thickness of the fibromuscular wall of the vagina.The vagina was closed without any resection of vaginal tissue.No ¿t incisions¿ were allowed to reduce the chance of mesh exposure in the patients with cuff prolapse.In all of the surgical groups, reported complications included urinary infection (n-5), febrile morbidity (n-5), perineal ecchymosis (n-5), and early mesh exposure (n-1).It was concluded that vaginal mesh procedures may be done with relatively fewer perioperative complications.However, there is a need for more randomized controlled.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7480944
• MDR Text Key: 107190669
• Report Number: 2210968-2018-72545
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2018

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: 04/03/2018
• Initial Date FDA Received: 05/02/2018
• 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