MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195512400

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Fever (1858); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Chills (2191); Numbness (2415); Intermenstrual Bleeding (2665); Foreign Body In Patient (2687); Peripheral Nervous Injury (4414); Hyperesthesia (4420); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced post-operative pain that is accentuated by sacroiliac joint pain inflammation, left sciatic pain, pain in her pelvis with radicular pain down her legs, posterior pelvic pain, left back pain, bilateral leg pain, left greater than right lower extremity pain, left groin and thigh with burning paresthesia to the feet and weakness and paresthesia, perineal pain, low back pain, neurapraxia, vaginal spotting with foul odor, chills, fever, heavy vaginal bleeding, tingling and pain from the left buttock and groin area to her left foot that started after pelvic surgery, spasm in her lower back and pelvis area, unable to sit or stand too long, hyperesthesia in the left leg on exam, possible nerve stretch to the sciatic nerve due to positioning during surgery, lumbar radiculopathy, debilitating 10 out of 10 pain, unable to tolerate her daily activities, piriformis muscle spasms, physical therapy exacerbated her symptoms, urge incontinence, type ii complex regional pain syndrome, lower limb obturator neuralgia, pudendal neuralgia disorder, spastic pelvic floor syndrome, numbness on the medial and posterior surface of both thighs, obturator spasms, neuropraxia secondary to surgical procedure, and muscle spasms radiating to her bilateral lower extremities to toes and to buttocks, left greater than right pain associated with a burning sensation and at times is a vibrating sensation.Patient had a left sacroiliac joint steroid injection and bilateral piriformis muscle trigger point injection.She reports a 10 out of 10 bilateral buttock pain radiating into her bilateral groin and lateral thigh prior to injections.Patient had explantation of the device, urethrolysis, cystoscopy under general anesthesia for vaginal pain, exposed vaginal foreign body, voiding dysfunction.The synthetic foreign body was identified spanning the mid to proximal urethra with evidence of exposure noted in the midline.Specimen was a 4.8 x 3.5 x 1.2 cm aggregate of two brown-gray firm, ragged and disrupted portions of device partially surfaced with soft tissue and muscle with adhesions.Patient had multiple complications and continues to have significant nerve pain.She has not been able to return to work because of the pain and cannot sit longer than 8 minutes at a time and this prevents her from being able to drive distances as well, spinal spasming in the lumbar area, tingling in the arm, hot burning in the upper left thigh with intense heat in the area.Patient had a bilateral pudendal nerve block, botox injection to pelvic floor muscles, bilateral removal of groin device under general anesthesia.Dense scar tissue with embedded piece of polypropylene was identified in the right adductor muscle fibers, dense scar tissue was noted on the left with visible fibers of polypropylene identified.Spasm of the obturator internus muscles bilaterally and left iliococcygeus muscle were noted and blood loss of 300 ml.Patient had hypotension and hypokalemia post-operatively.Pathology noted in the right groin foreign device material with embedded and attached soft tissue measuring 3 x 1.4 x 0.4 cm, left groin foreign device material with embedded and attached soft tissue measuring 3.2 x 1.5 x 0.5 cm.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15911822
• MDR Text Key: 304772197
• Report Number: 2125050-2022-01341
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2022

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
• Device Expiration Date: 09/30/2022
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 6136140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/02/2022
• Date Device Manufactured: 02/22/2018
• 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): Required Intervention
• Patient Age: 68 YR