MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number GPSL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.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.The patient demographic info: age, weight, bmi at the time of index procedure date of initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications.Lot number? what is physician¿s opinion as to the etiology of or contributing factors to this event? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and results.What is the patient's current status?.

Event Description

It was reported that the patient underwent a sacrocolpopexy procedure on (b)(6) 2009 and the mesh was implanted.On (b)(6) 2015 the patient experienced vaginal spotting.Per the patient, minor has ticked.On (b)(6) 2017 the patient was diagnosed with mesh erosion as mesh being bunched up and required further surgery to remove the mesh.Currently, the mesh is still implanted.Additional information has been requested.

• Brand Name: GYNECARE GYNEMESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6864484
• MDR Text Key: 86112442
• Report Number: 2210968-2017-70281
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GPSL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2017
• 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