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 Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271); Not Applicable (3189)

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: int urogynecol j (2016) 27:1497¿1505, doi 10.1007/s00192-016-3012-x, published online: 1 april 2016.(b)(4).

Event Description

It was reported via journal article title: "comparison of the efficacy of tension-free vaginal tape obturator (tvt-o) and single-incision tension-free vaginal tape (ajust¿) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial." authors: jaromir masata & kamil svabik & karel zvara & petr hubka & ales toman & alois martan.Citation: int urogynecol j (2016) 27: 1497¿1505, doi 10.1007/s00192-016-3012-x, published online: 1 april 2016.The aim of this current randomized study was to compare the efficacy of the tension-free vaginal tape obturator (tvt-o) and single-incision tension-free vaginal tape (ajust¿) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up.Between may 2010 and may 2012, a total of 100 women with proven sui were randomized, 50 in the tvt-o group and 50 in the ajust group.Each patient received the planned surgery as allocated (there was no need to convert planned surgery to another type).The mean age of the whole group was 57.4 years (sd 11.4 years), mean bmi 27.6 kg/m2 (sd 4.6 kg/m2), mean parity 2.0 (sd 0.7), mean iciq-ui sf score 14.7 (sd 2.5) and iqol score 39.8 (sd 18.1), mean maximum urethral closure pressure 54.7 cm h2o (sd 21.6 cm h2o) and mean maximum flow rate 25.1 ml/s (sd 12.8 ml/s).Transient postoperative urine retention occurred in one patient in the tvt-o group (the patient underwent surgical early tape release).Urinary tract infection occurred in 5 patients.There were 47 patients who complained postoperative pain: day 1- (53.1 ± 28.9); day 2- (37.6 ± 27.1); day 3- (28.4 ± 25.4); day 4- (18.0 ± 19.9); day 7- (7.9 ± 11.1) with 6.4 ± 3.6 as the mean duration of days of pain.De novo urgency (n=4) and failure (n=1) were reported.In conclusion, after a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape ajust and tvt-o.

• 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: 7940426
• MDR Text Key: 123072096
• Report Number: 2210968-2018-76350
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 09/12/2018

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: 09/12/2018
• Initial Date FDA Received: 10/05/2018
• 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