MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

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

Patient Problems Fever (1858); Hematoma (1884); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271)

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.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: european journal of obstetrics & gynecology and reproductive biology 222 (2018) 146¿150; doi: https://doi.Org/10.1016/j.Ejogrb.2018.01.028.(b)(4).

Event Description

It was reported via journal article "title: prevalence and risk factors for urinary tract infection up to one year following midurethral sling incontinence surgery" author: adi y.Weintrauba, yonatan reuvenb, dorit paz-levya, zehava yohaya, inbal idana, debi elharara, hannah glintera, tamar tzurc, david yohaya.Citation: european journal of obstetrics & gynecology and reproductive biology 222 (2018) 146¿150; doi: https://doi.Org/10.1016/j.Ejogrb.2018.01.028.This retrospective cohort study aimed to investigate the prevalence and risk factors of urinary tract infection (uti) one year following sub-midurethral sling (smus) incontinence surgery in a university affiliated medical center in southern israel.Between 2014 and 2015, 178 female patients with stress urinary incontinence underwent smus incontinence surgery.All procedures were transobturator slings (either gynecare tvt abbrevo continence system or gynecare tvt obturator system).Within the first year following the surgery, 38 patients developed uti (mean age sd of 64.8±11.5 years) treated with antibiotics.Three of these patients were complicated with perineal hematoma and one patient had postoperative fever.Of the 140 patients without uti (mean age sd of 61.1±12.3 years), outcome included postoperative fever (n=1), blood transfusion after surgery of the patients who experienced longer hospitalization (>4 days), reasons included urinary retention (n=2) and groin hematoma (n=1).Of the patients who were re-hospitalized within 1 year, reasons included urinary retention (n=1) which resolved spontaneously two days later, pyelonephritis/urosepsis (n=3), suspected infected hematoma in the vaginal stump (n=5), recurrence of prolapse (n=2) and failure of sling (n=1).Twelve patients had recurrent uti.Of the 38 patients with uti, 13 responded to antibiotics and 25 were antibiotic resistant.One of these patient had antibiotic during hospitalization.The authors concluded that antibiotic prophylaxis does not seem to offer any benefit in smus procedures and that pre-operative recurrent uti was the strongest risk factor for postoperative uti.Approximately one in every five women undergoing a smus operation will suffer from uti within 12 months from surgery.This rate is similar to that reported in the literature.A significant association was found between the duration of hospitalization and readmissions in the first postoperative year and suffering from uti.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7945093
• MDR Text Key: 123057809
• Report Number: 2210968-2018-76387
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K033568
• 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: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• 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: 09/14/2018
• 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