MAUDE Adverse Event Report: CALDERA MEDICAL INC. T-SLING; SURGICAL MESH

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

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

Event Type  Injury  

Manufacturer Narrative

The lot number used is unknown and the product is not available for investigation.Based upon the details presented, it is unknown if the complaint as described is a result of the device, surgical procedure, or patient history.The potential for adverse reactions such as infection, inflammation, foreign body response are known events and are listed in the product ifu in the adverse reactions and contraindications sections.Although there are known risks associated with the use of caldera medical's mesh products, when used properly, the benefit to the patient for the intended use outweighs these risks.

Event Description

Caldera medical received the letter from fda mdr team stating that report mw5096477 was received through fda's medwatch program.On the report mw5096477 it was stated that patient had laparoscopy sacrocolpopexy mesh procedure in 2008 with johnson and johnson mesh, ethicon's gynecare, and caldera's t-sling.The doctors detected an "infection or active repair process" by doing a pap smear prior to the procedures and elected to do the surgery anyway.Two weeks after surgery patient developed an abscess that required a drain tube placed through her abdomen.She was hospitalized for four days.In 2016 hydrodistention cystoscopy was performed that diagnosed interstitial cystitis, and to provide relief from pain.In 2019 the hydrodistention procedure was performed again.Patient did not experience any relief after hydrodistention procedures.Over the next 12 years patient is getting progressively worse: pelvic pain, groin pain, pudendal nerve pain, pain in the obturator foramen, back pain in the sacrum, pain shooting down her right leg (the infection was on the right side), pain in her hip, muscular atrophy in her gluteal muscles and her right leg.Nerve problems in her right tibial nerve, most likely related to the nerve injury in her groin fatigue, muscular aches similar to fibromyalgia, occasional fevers with no known origin bladder pain.Interstitial cystitis 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 her side most of the day.Sclerotic focus in the right sacral ala.Quality of patient's life was destroyed.Patient is generally feeling ill for no known reason except a possible poisoning from the mesh.In the year of 2013, 2016, and 2019 patient brought concerns to the surgeon regarding the mesh, that was dismissed or ignored.Patient is suffering around 12 years and cannot find or afford a surgeon to remove the mesh.Patient is seeking legal action.

• Brand Name: T-SLING
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• Manufacturer (Section G): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• Manufacturer Contact: ieva sirokoviene ; 5171 clareton drive; agoura hills, CA 91301 ; 8184837641
• MDR Report Key: 10733366
• MDR Text Key: 212995461
• Report Number: 3003990090-2020-01520
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability