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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123); Discomfort (2330); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a gynecological procedure for prolapse in 2009 and mesh was implanted.The patient experienced partial vaginal exposure, causing offensive discharge along with discomfort and vaginal bleeding.In 2018, the patient underwent another procedure and the exposed area of mesh was excised under general anesthetic.No additional information has been provided.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: the patient demographic info: age (b)(6).Gender female.Weight (b)(6).Bmi at the time of index procedure unsure as the index procedure was not at this hospital.Current bmi 23 date and name of index surgical procedure (b)(6) 2009 abdominal sacrocolpopexy.The initial approach for the index surgical procedure abdominal.Any concurrent procedure / device implantation? mesh insertion for prolapse.When was the mesh exposure first noted by a physician? referred from her original consultant in (b)(6) 2017.Mesh exposure site/location, symptoms and diagnostic confirmation? exposure of mesh at vaginal vault.Symptoms of vaginal discharge.Were there any intraoperative complications? unknown.This procedure was carried out at another hospital.Product code and lot #? n/a.What is the patient¿s current status? at home.Has recovered well after excision of exposed mesh.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7506904
• MDR Text Key: 108006393
• Report Number: 2210968-2018-72739
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 59