MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Inflammation (1932); Itching Sensation (1943); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Fungal Infection (2419); Hematuria (2558); Dysuria (2684); Constipation (3274); Kidney Infection (4502); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced pelvic pain, vaginal discharge, vaginal pain when sitting, pain with sitting and pressure in the pelvis, recurrent bacterial vaginosis, lower quadrant abdominal pain in the suprapubic region, vaginal irritation, tender cervix, burning involving lower pelvic region bilaterally, dyspareunia with deep penetration, vaginal burning with odor, dysuria, urinary tract infection symptoms, urinary frequency, urgency, urinary incontinence, urinary retention, hematuria, mild low back pain, right side back pain, urethritis, pelvic discomfort, cystoscopy, difficulty with sitting, burning with urination, dark brown pelvic discharge, tingling in lower extremities, pelvic pressure and burning, thighs and tailbone feel inflamed, vaginal itchiness, yeast vaginitis, burning sensation in lower abdomen, vaginal discomfort, mild discomfort with urination, right lateral leg pain, burning in right groin area, physical exam found to have tender nodule located lateral to the urethra on her right which appeared to be rolled up device, right leg nerve pain, perineal pain, bladder pressure, pelvic floor dysfunction, pyelonephritis, meralgia paresthetica, right lateral thigh burning pain that is worse with prolonged sitting, right lower quadrant and suprapubic region that is tender to palpation, flank pain, right groin pain, right side pelvic pressure, right side burning abdominal pain that radiates to right thigh, pressure in rectum and vagina, and a pelvic floor therapy evaluation.Patient has had problems since device was placed, tingling and nerve pain began three months after placement, constipation issues and right sided abdominal pain six months after placement and symptoms returned 4 months after device explantation.Patient had a right lateral femoral cutaneous nerve block performed for right meralgia paresthetica.Patient had robotic explantation of the device under general anesthesia.Intraoperative findings noted a ball of device located near the right pelvic sidewall directly lateral from the mid urethra and extended into the obturator muscle.The left side of the device appeared inert.No significant adhesions were noted around it.Pathology report included explanted device with blood and particles of soft tissue measuring 1.6 x 0.7 x 0.2 cm.

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.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• 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: 15789814
• MDR Text Key: 303573633
• Report Number: 2125050-2022-01247
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• 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: 11/14/2022

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: 08/26/2021
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6273602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/14/2022
• Date Device Manufactured: 08/27/2018
• 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: 35 YR