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 Wound Dehiscence (1154); Extravasation (1842); Urinary Tract Infection (2120)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 2210968-2022-05396.Citation: https://doi.Org/10.1016/j.Urology.2020.12.014.

Event Description

Title: glans preservation in surgical treatment of distal urethral strictures with dorsal buccal mucosa graft onlay by subcoronal approach.The objective of this study is to describe dorsal onlay buccal mucosa graft urethroplasty technique by subcoronal approach and glans preservation in distal penile urethral strictures with fossa navicularis involvement and to report safety, effectiveness, and cosmetic outcomes.Retrospective review of prospectively collected database including all men with dus+fn who underwent dorsal onlay bmg by subcoronal approach and glans preservation in the genitourinary reconstructive surgery division at hospital italiano de buenos aires, between january 2011 and december 2019.5/0 polyglactin 910 suture and 5/0 polydioxanone suture was used.Reported complications included wound dehiscence (n=1), intercurrent urinary tract infection (n=1), urinary extravasation (n=1).In conclusion for treatment of distal penile urethral strictures with fn involvement, dorsal onlay bmg by subcoronal approach and glans preservation is a feasible technique with excellent functional long-term outcomes, with minimal complication rates and substantial cosmetic results.

• 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: 14991291
• MDR Text Key: 295767927
• Report Number: 2210968-2022-05397
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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: 06/21/2022
• 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