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

Catalog Number MESHUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Discomfort (2330); Not Applicable (3189)

Event Date 06/29/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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.

Event Description

It was reported that the patient underwent a surgical procedure/ sacrocolpoplexy on (b)(6) 2007 and the mesh was implanted for vaginal prolapse. The patient started to experience vaginal discharge, continual infection and severe discomfort. It was also reported that the patient could feel sharp prongs protruding through the vaginal wall. This condition worsened until the partial removal of the protruding mesh. From that point the condition got worse with increasingly heavier discharge, infection, incontinence and sharp abdominal pain. More of the mesh was protruding through the vaginal wall. Additional information has been requested. After second opinion and ultrasound which confirmed, the mesh had eroded and formed a mass which was causing the pain, discharge and infection. The patient required the mesh to be removed immediately. It was also reported that the date of explantation was (b)(6) 2018. No further information is available.

• 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.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8263168
• MDR Text Key: 133706458
• Report Number: 2210968-2019-78493
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: MESHUNK
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/20/2019 Patient Sequence Number: 1