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

Device Problem Migration (4003)

Patient Problem Erosion (1750)

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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that 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 the ethicon products involved? citation: int urogynecol j (2013) 24:1123¿1126, doi 10.1007/s00192-012-1961-2, published online: 3 november 2012.(b)(4).

Event Description

It was reported via journal article: "title : lack of effect of concomitant stage ii cystocele repair on lower urinary tract symptoms and surgical outcome after tension-free vaginal tape procedure: randomized controlled trial" author: hyoung keun park , sung hyun paick , yong soo lho , gwoan youb choo , hyeong gon kim , jaekyung choi citation: int urogynecol j (2013) 24:1123¿1126, doi 10.1007/s00192-012-1961-2, published online: 3 november 2012.The aim of this comparative study was to evaluate the lower urinary tract symptom changes and surgical outcome between the tension-free vaginal tape (tvt) procedure with and without concomitant stage ii pelvic organ prolapse (cystocele) repair in a randomized clinical trial setting.Between march 2008 and june 2010, 99 women were successfully randomized and included in the study.The final analysis was performed in 91 cases (45 in the tvt only group and 46 in the concomitant cystocele repair group).During the procedure, the cystocele repair procedure was performed with gynemesh.Although there was no case of erosion in the tvt only group, two cases of vaginal erosion were identified in the concomitant repair group during the follow-up period.In conclusion, in patients with stage ii cystocele and sui, there was no difference in the surgical outcome and lower urinary tract symptoms between the tvt sling only group and concomitant repair group.Cystocele repair can be safely omitted in patients with stage ii cystocele.

• 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 PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7749981
• MDR Text Key: 116042240
• Report Number: 2210968-2018-74888
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2018
• 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: 07/19/2018
• 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