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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via journal article: "title: a pilot study on vaginally assisted laparoscopic sacrocolpopexy for patients with uterovaginal prolapse." author: walter s.Von pechmann, md, matthew j.Aungst, md,þ daniel d.Gruber, md,þ pari m.Ghodsi, md, david f.Cruess, phd, cph,þ and kenneth r.Griffis.Citation: female pelvic med reconstr surg 2011;17: 115y119.The primary objective of the study was to compare the short-term anatomic outcomes and complication rates between the 2 groups with secondary objective to determine whether transvaginal mesh attachment to the vaginal apex resulted in shorter operative times than laparoscopic mesh attachment to the vaginal apex.Seventy patients with uterovaginal prolapse were included.Between 01-jan-2006 and 31-dec-2008, 26 female patients (mean age sd of 55.8 years [11.5 years]) underwent laparoscopic sacrocolpopexy (ls); and between 01-jan-2007 and 31-dec-2008, 47 female patients (mean age sd of 59.4 years [9.6 years]) underwent vaginally assisted laparoscopic sacrocolpexy (vals).Ls and vals utilized gynemesh or prolene soft which were sutured to the upper anterior and posterior vaginal walls using ethibond/nylon (ls group) and goretex/nylon (vals group).In vals group, postoperative complications included ileus (n=1) which responded to conservative treatment and mesh extrusion (n=1) which was managed with continued observation only.There was no significant difference in short-term anatomic outcomes or complication rates between groups.

• Brand Name: GYNECARE 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.; 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: 7746737
• MDR Text Key: 115916817
• Report Number: 2210968-2018-74874
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• 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: 07/11/2018
• 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