MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number PROMESHUNK

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

Patient Problems Incontinence (1928); Injury (2348); Not Applicable (3189)

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: hong kong med j (2011);17(1):54-60.(b)(4).

Event Description

It was reported in a journal article with title: laparoscopic sacrocolpopexy for the treatment of vaginal vault prolapse: with or without robotic assistance.The aim of this study is to assess perioperative and medium-term outcome after laparoscopic sacrocolpopexy with or without robotic assistance for vaginal vault prolapse in a hong kong tertiary centre.This retrospective study involves 36 female patients (66.8±8.2 years) who underwent laparoscopic sacrocolpopexy for vaginal vault prolapse from march 2005 to may 2010.From 2005 to 2007, 20 female patients underwent laparoscopic sacrocolpopexy (ls) and from mid 2007, 16 patients underwent the robotic assisted laparoscopic sacrocolpopexy (rals).A y-shape polypropylene mesh (ethicon) was prepared and was introduced, with the two distal arms anchored to the anterior and posterior vaginal wall respectively, using 2 to 3 stitches on each side.The proximal arm was anchored to the longitudinal sacral ligament using interrupted absorbable sutures, except that titanium helical tacks were used in two patients.In ls, four ports were used while a total of four or five ports were introduced in rals.Reported complications in ls group included bladder injury related to sacrocolpopexy (n-?) which was repaired, de-novo stress incontinence (n-?), de-novo urinary urgency (n-?), de-novo urge incontinence (n-?), recurrence of stage ii prolapse (n-3), recurrence of stage iii prolapse (n-1).In rals group, reported complications included bladder injury related to sacrocolpopexy (n-?) which was repaired, de-novo stress incontinence (n-?), de-novo urinary urgency (n-?), de-novo urge incontinence (n-?), recurrence of stage ii prolapse (n-2).One patient with recurrence of stage ii prolapse in each ls and rals group had reoperation by total vaginal mesh repair, and another one preferred to have conservative management.In conclusion, laparoscopic sacrocolpopexy for vaginal vault prolapse is safe, although complications arising from concomitant surgery should not be neglected.Laparoscopic sacrocolpopexy should be considered an option for women with vaginal vault prolapse.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8898868
• MDR Text Key: 154566910
• Report Number: 2210968-2019-85643
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• 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