MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Frequency (2275)

Event Date 03/24/2021

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 additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the author/surgeon believe that ethicon products (pds ii suture) involved caused and/or contributed to post-op complications (de novo stress urinary incontinence, pelvic pain, recurrences, frequency, urgency, urinary incontinence, nocturia, hesitancy, dysuria, feeling of incomplete emptying, stress urinary incontinence, low backache, constipation, vaginal bulging and dyspareunia) described in the article? please specify.Does the author/surgeon believe there was any deficiency with the ethicon products (pds ii suture) used in this study? if yes, please describe.If yes, please provide patient demographics for patients that experienced the post-operative complications (de novo stress urinary incontinence, pelvic pain, recurrences, frequency, urgency, urinary incontinence, nocturia, hesitancy, dysuria, feeling of incomplete emptying, stress urinary incontinence, low backache, constipation, vaginal bulging and dyspareunia)? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: european journal of obstetrics & gynecology and reproductive biology 260 (2021) 212¿217; https://doi.Org/10.1016/j.Ejogrb.2021.03.0350301-2115/.

Event Description

Title: quality of life recovery after laparoscopic high uterosacral ligament suspension: a single centre observational study this retrospective observational study aims to analyze quality of life, sexual function and patients¿ satisfaction rates among patients who underwent laparoscopic high uterosacral ligament suspension (lhusls) in our urogynecological department with a high grade of apical prolapse after a median follow-up time of 2 years.Between january 2016 and january 2018, 60 patients underwent laparoscopic high uterosacral ligament suspension (lhusls).Polydioxanone sutures (pds1; ethicon, (b)(4), usa) was use in all surgical procedures.The first stitch is placed on the corner of vaginal vault including pubocervical fascia and rectovaginal fascia.Two additional sutures were placed medially to the initial suture.The same procedure was carried out on the opposite side, with the goal of placing three suspensory sutures on each side.Every needle passage was always performed under direct visualization of ureter, hypogastric nerve, rectum and bladder in order to avoid complications.The median follow-up was 24 months (range, 24-48).Reported complications included: (n=4) cases of de novo stress urinary incontinence.(n=2) patient with pelvic pain which resolved within 3 weeks with analgesic drug.(n=10) recurrences.At 24-month follow-up: (n=8) frequency , (n=14) urgency , (n=10) urinary incontinence , (n=4) nocturia , (n=8) hesitancy, (n=2) dysuria, (n=10) feeling of incomplete emptying, (n=16) sui, (n=4) low backache, (n=8) constipation, (n=4) vaginal bulging, (n=6) dyspareunia.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 - f07 -nocturia, hesitancy, dysuria, feeling of incomplete emptying, constipation, vaginal bulging, dyspareunia.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12708269
• MDR Text Key: 285096027
• Report Number: 2210968-2021-10447
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• 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