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

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2017

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: int urogynecol j (2017); 28:1567¿1572.Doi 10.1007/s00192-017-3310-y.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 product (tension free vaginal tape - exact) 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 product involved? patient demographics.

Event Description

It was reported in a journal article with title: two techniques for assessing postoperative voiding function, a randomized trial.The primary outcome of this parallel non-blinded, randomized controlled trial was to hypothesize that an or-initiated retrograde vt after outpatient mid-urethral sling placement, with or without an anterior repair, would decrease total pacu time compared with a retrograde vt initiated in the pacu.Secondary outcomes included assessing patient satisfaction with the two vt methods and assessing voiding parameters, including the risk for overdistention.Between november 2011 and april 2014, a total of 59 women who were planning to undergo mid-urethral sling placement with no history of previous incontinence surgery were included in the study.30 women (mean age = 52.0 ± 9.7 years; bmi = 29.0 ± 6.0) were assigned to the or-fill group and 29 women (mean age = 54.6 ± 13.1; bmi = 29.3 ± 4.7) to the pacu-fill group.Tvt-exact (ethicon) retropubic slings was used in 18 patients in the or-fill group and 19 patients in the pacu-fill group, while the rest of the patients used a competitor device.Reported complications included failed in vt (n=?); pain report after vt based on median vas scores (n=?); median post void residual of 386.5 or 250 (n=?); dissatisfaction (n=?); postoperative hematoma (n=1) that resolved spontaneously; infection at the retropubic trocar site (n=1), which resolved with antibiotic treatment.All postoperative voiding dysfunction (n=?) resolved before the 6-week postoperative visit, and no sling revisions were performed.In conclusion, or-fill vt did not decrease total pacu time compared with pacu-fill vt; however, time to vt initiation was decreased and no subjects were found to have overdistention.If a vt can be performed earlier in the recovery period, this may offer the potential to explore other opportunities for faster discharge.Additionally, it may allow for an earlier second attempt at vt for women who fail the first vt.Given the high rate of short-term urinary retention after mid-urethral sling in our patient population, optimizing the postoperative vt technique is essential.

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT 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: 11929016
• MDR Text Key: 266935515
• Report Number: 2210968-2021-05201
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2021

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: 05/05/2021
• Initial Date FDA Received: 06/03/2021
• 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