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 Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/21/2020

Event Type  Injury  

Event Description

Title: laparoscopic uterosacral ligament suspension versus vaginal colposuspension using the uphold lite¿ mesh system: clinical outcome and patient satisfaction.The objective was to compare clinical and anatomical outcomes between laparoscopic uterosacral ligament suspension (lusls) and vaginal colposuspension using the uphold lite¿ mesh system for the treatment of apical prolapse.A comparative, retrospective cohort study.All women who underwent either vaginal colposuspension with the uphold lite¿ system or lusls for treatment of apical prolapse between 2010 and 2019 were included.The groups were compared with regard to demographic, pre-operative, intra-operative, and post-operative data.One-hundred and nineteen women met the inclusion criteria, including 70 women who underwent lusls and 49 women who underwent vaginal colposuspension with the uphold lite mesh system.The mesh was sutured to the cervix with a 2¿0 polypropylene suture (prolene) and secured to the endopelvic fascia at the bladder neck with a 2¿0 pds suture.The mesh arms were then pulled, elevating the vaginal apex without undue tension.Cystoscopy was performed to verify bladder integrity and ureteral patency.A full thickness closure of the vaginal incision was carried out using a 2¿0 vicryl suture ethicon.Reported complications included recurrence prolapse, sui recurrence, urge incontinence, dyspareunia and recurrent uti.In conclusion laparoscopic uterosacral ligament suspension and vaginal colposuspension using the uphold lite mesh system both have high clinical cure rates.

Manufacturer Narrative

(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.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.Does the surgeon believe that any of the 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 any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-05545, 2210968-2022-05547.Citation: https://doi.Org/10.1007/s00192-020-04563-3.

• 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 ; 9083863534
• MDR Report Key: 15028701
• MDR Text Key: 295977817
• Report Number: 2210968-2022-05546
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female