MAUDE Adverse Event Report: CALDERA MEDICAL, INC. CALDERA T SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Fever (1858); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Urinary Frequency (2275); Malaise (2359); Dyspareunia (4505)

Event Type  Injury  

Event Description

On (b)(6) 2008; procedure: laparoscopy sacrocolpopexy mesh (johnson and johnson and ethicon product gynecare gynemesh prolene soft.) apical prolapse; mesh placed at the time of hysterectomy for vaginal prolapse.Cysto w/bladder dilation \ r/o interstitial cystitis \ gyn / hydrodistension, hysterectomy, vaginal sling procedure with synthetic fascia \ gyn / t-sling, trans obturator (caldera t-sling), morcellator was used, the doctors detected an "infection or active repair process" by doing a pap smear prior to the procedures on (b)(6) and elected to do the surgery anyway.The pap smear was performed on (b)(6) 2008.One day after the surgery my white blood count was high and i was released from the hospital.2 weeks later (b)(6) 2008: developed an abscess that required a drain tube placed through my abdomen.Hospitalized for 4 days.On (b)(6) 2016 hydrodistention cystoscopy performed that diagnosed interstitial cystitis, and to provide relief from pain.On (b)(6) 2019 the hydrodistention procedure performed again.No relief.Over the next 12 years getting progressively worse: pelvic pain, groin pain, pudendal nerve pain, pain in the obturator foramen, back pain in the sacrum, pain shooting down my right leg (the infection was on the right side), pain in my hip, muscular atrophy in my gluteal muscles and my right leg.Nerve problems in my right tibial nerve most likely related to the nerve injury in my groin fatigue, muscular aches similar to fibromyalgia, occasional fevers with no known origin bladder pain, interstitial cystitis (ruled out prior to hysterectomy and mesh procedures) developed since self-catheterization many times a day, painful bowel movements, lower back pain after a bowel movement; movement severely limited to being on the couch or bed on my side most of the day.Quality of life destroyed sex life nearly non-existent due to pain in certain positions and pain after intercourse.Generally feeling ill for no known reason except a possible poisoning from the mesh.Sclerotic focus in the right sacral ala.2013; 2016; 2019 brought concerns to the surgeon regarding the mesh that was dismissed or ignored; 12 years of suffering and cannot find or afford a surgeon to remove the mesh.Seeking legal action.This mesh has to come out.It has destroyed my life.I just graduated from law school and cannot return to work or sit for the bar exam because the pain is so extreme.Fda safety report id# (b)(4).

• Brand Name: CALDERA T SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): CALDERA MEDICAL, INC.
• MDR Report Key: 10507379
• MDR Text Key: 206382757
• Report Number: MW5096477
• Device Sequence Number: 1
• Product Code: PWJ
• 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: 09/03/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 109