MAUDE Adverse Event Report: CERVICAL MESH; MESH SURGICAL, SYNTHETIC UROGYNECOLOGIC

Device Problems Migration or Expulsion of Device (1395); Nonstandard Device (1420)

Patient Problems Unspecified Infection (1930); Discomfort (2330)

Event Date 06/07/2017

Event Type  Injury  

Event Description

In 2009, i had a cervical stitch implanted so that i could have a successful pregnancy.After delivery, the doctor did not remove the mesh stitch and i began to have complication a few years later.The symptoms became worst and i changed doctors to get better answers.After several test, the results showed that the cervical stitch had shifted and become embedded in my cervical wall causing infection, tearing, discomfort, bad odor and had become harden.The doctor removed the cervical stitch and had to perform a d and c.I am asking that you help me to find out if there is any recall info on cervical stitch.

• Brand Name: CERVICAL MESH
• Type of Device: MESH SURGICAL, SYNTHETIC UROGYNECOLOGIC
• MDR Report Key: 6809686
• MDR Text Key: 83454343
• Report Number: MW5071732
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 73