MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSVAGINAL BLADDER MESH, AND UMBILICAL MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Device Problem Output Problem (3005)

Patient Problems Bacterial Infection (1735); Fistula (1862); Unspecified Infection (1930); Pain (1994); Prolapse (2475); Ambulation Difficulties (2544); Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/12/2007

Event Type  Injury  

Event Description

I have had three surgeries for bladder issues in 2007, 2009, and 2011 and after all of them i have had nothing but continual problems with my body, and several other surgeries after the bladder mesh was put into me that no one will medically follow up with.I have several boil type infections in my hips, around my vagina, all over in between my the pits of my legs.I feel like i am wearing a huge ball of tin foil inside me, there is fistula they cannot feel my ovaries, the mesh is prolapsed, and i cannot have a sexual relationship due to pain, and infections.I have had brown discharge now, it is pink and green discharge, several high levels of bacterial vaginosis, it is affecting my legs, and i can barely walk with horrible pain in my legs.I also have umbilical hernia mesh that complicates things too.It is causing excessive pain in my belly and between the bladder mesh, and umbilical mesh.It has made voiding very painful and sometimes i can not void right.My doctors refuse to care for me due to another medical establishment putting these things into me, so finding a doctor whom will help is impossible so i've gone years without really proper medical treatment, and have lost a lot of my proper medical treatments because they say there is nothing they can do for me yet i am full body disabled and continual body loss with no proper medical treatment.

• Brand Name: TRANSVAGINAL BLADDER MESH, AND UMBILICAL MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 16148572
• MDR Text Key: 307287715
• Report Number: MW5114293
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADDERALL; CITIRIZINE; LEXAPRO; ULTIMATE FISH OIL; ZANAX
• Patient Outcome(s): Other; Disability
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White