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

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

Patient Problems Neurological Deficit/Dysfunction (1982); Urinary Tract Infection (2120); Injury (2348)

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.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 products (tvt) 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 (tvt) used in this procedure? citation: open journal of obstetrics and gynecology.2014; 4: 169-175.Doi: http://dx.Doi.Org/10.4236/ojog.2014.43028.(b)(4).

Event Description

It was reported via journal article: title: "treatment success of transobturator tape compared with tension free vaginal tape for stress urinary incontinence at 24 months: a randomized controlled trial." authors: mahmoud fathy hassan, osama el-tohamy, mostafa kamel.Citation: open journal of obstetrics and gynecology.2014; 4: 169-175.Doi: http://dx.Doi.Org/10.4236/ojog.2014.43028.The objectives of the study was to compare the long term efficacy of transobturator tape (tot) with tension free vaginal tape (tvt) at 24 months postoperatively.A total of 160 women with stress urinary incontinence (sui) were randomly allocated to either tvt (n-80; age: 53.1 ± 8.1; bmi: 29.9 ± 5.5) or tot (n-80; age: 51.6 ± 7.9; bmi: 30.4 ± 4.9) procedures and reviewed at 24 months after surgery.The tvt procedure was performed using the ¿bottom up¿ approach following the technique described by the manufacturer using gynecare tvt (ethicon).In the tvt group, reported complications included urinary tract infection (n-10), voiding dysfunction (n-8), and bladder perforation (n-3).It was concluded that there were no significant differences in objective and subjective outcomes between women who had tot or tvt procedures at 24 months follow up.Both procedures had similar complication rate.However, tot procedure had a shorter operating time.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• 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: 8209484
• MDR Text Key: 131829786
• Report Number: 2210968-2019-78111
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K974098
• 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: 12/12/2018

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: 12/12/2018
• Initial Date FDA Received: 01/02/2019
• 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