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 Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 08/24/2021

Event Type  Injury  

Event Description

Title: outcome analysis of dorsal buccal mucosal graft urethroplasty in perimenopausal women with urethral stricture disease.The purpose of this study is to assess the clinical outcomes following dorsal buccal mucosal graft urethroplasty (bmgu) in perimenopausal women (pmw) suffering from urethral stricture disease.Between march 2014 and march 2020, 8 patients with pmw underwent bmgu.The mean age of the patients is 52.1 years.3-¿0¿chromic catgut (chromic gut® ethicon inc., usa).Was used to close the harvested area for the graft.4-¿0¿ polydioxanone (pds® ethicon inc., usa) sutures were used for the urethroplasty.Urethral site complications (n=5) clitoral edema.(n=4) splaying of urinary stream.(n=1) stricture recurrence.Donor site complications (n=2) restriction of mouth opening.(n=3) oral numbness or pain.(n=1) facial swelling.In conclusion, dorsal bmgu in females for urethral stricture disease offers successful urethral reconstruction and the advantage of least disruption of continence mechanism and resilience to hormonal changes in pmw.

Manufacturer Narrative

Product complaint # (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? which specific ethicon products have been used during the procedures (product code, lot number)? 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.Citation: iyyan ab, murugan pp, rajagopal sv, sali sa.Outcome analysis of dorsal buccal.Mucosal graft urethroplasty in perimenopausal women with urethral stricture.Disease.Urol sci 2022;33:26-9.Https://doi.Org/10.4103/uros.Uros_85_21.

• 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: 15681327
• MDR Text Key: 302502183
• Report Number: 2210968-2022-08845
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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: 10/13/2022
• 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): Required Intervention