MAUDE Adverse Event Report: UNKNOWN TVT TRANSVAGINAL MESH FOR THE SURGICAL REPAIR OF PELVIC ORGAN PROLAPSE; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSV

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Fatigue (1849); Pain (1994); Ambulation Difficulties (2544); Cognitive Changes (2551); Device Embedded In Tissue or Plaque (3165); Dyspareunia (4505)

Event Date 11/29/2017

Event Type  Injury  

Event Description

I received transvaginal mesh for the surgical repair of pelvic organ prolapse in (b)(6) 2017 in (b)(6) hospital, israel, since then i have difficulty walking.I get tired fast.It's hard to concentrate pelvic and groin pain.I had a wire near my groin for 11 months.During 11 months i had pain with sex.The wire fell by itself.Now the wire is inside the body and stabbing me in the area inside the body.I can touch it.My life has changed, i'm less active, meet with friends less, tired and in pain.Taking painkillers and cannabis.I have a lot of medical expenses.There are doctors who are willing to operate on me but i am afraid.The health insurance fund does not finance all expenses.Electromyography ultrasonogram.Fda safety report id #(b)(4).

• Brand Name: TVT TRANSVAGINAL MESH FOR THE SURGICAL REPAIR OF PELVIC ORGAN PROLAPSE
• Type of Device: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSV
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15865007
• MDR Text Key: 304424064
• Report Number: MW5113488
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: IL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2022
• Patient Sequence Number: 1
• Treatment: CANNABIS, LYRICA, ZALDIAR, PEPTAMEN.
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White