MAUDE Adverse Event Report: HERNIA MESH

Device Problems Break (1069); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Numbness (2415)

Event Date 04/14/2012

Event Type  Injury  

Event Description

To tell you what happened: 2002 i had surgery to close a hernia in pelvic muscle.In (b)(6) 2012 i fell causing mesh that was used over hernia to break loose.I was referred to a surgeon who placed another mesh over this hernia.I had complication in surgery, and after surgery, a hematoma.I felt when this mesh broke away and is still broken.It causes pain in my right leg and pelvic area.It causes numbing in my right pelvic area and upper thigh.I am too afraid to have any more surgery for this due to last complication, my age and current health.In the surgery, the surgeon continued to use latex.I have an allergy to latex.I am not remembering the spelling of dr (b)(6), nor the surgery office she worked or works with.The product was different in shape than the mesh placed in me in 2002, by dr (b)(6).I do not have exact date.The date of injury listed in this complaint is the correct month and year, but the exact day i tell i do not remember.I know my surgery came within a two month period of my fall that broke away the mesh that was placed in the year 2002.The 2002 mesh was placed in by dr (b)(6).Its design was different from the current mesh in me.Dr.(b)(6) (spelling) placed mesh in 2012.Other complication with this surgery could have been due to her continued use of latex even after i had reminded her of my allergy to latex.My dates are best i can remember.Diagnosis or reason for use: to cover a hole (hernia) in pelvic muscle."is the product compounded: yes, is the product over-the-counter: no, event abated after use stopped or dose reduced: no.".

• Brand Name: HERNIA MESH
• Type of Device: HERNIA MESH
• MDR Report Key: 6736509
• MDR Text Key: 80987951
• Report Number: MW5071172
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/20/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 57 YR
• Patient Weight: 104