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

Model Number 5196502400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Burning Sensation (2146); Urinary Frequency (2275); Fungal Infection (2419); Dysuria (2684); Dyspareunia (4505); 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 an emergency department visit for pyelonephritis, urinary tract infections with positive culture e.Coli, extended spectrum beta-lactamases, urinary tract infections positive with enterococcus, emergency department visit for bacterial vaginosis, burning inside vagina, pain where device is located, tugging feeling that comes and goes on right side, vulvar pain, vaginal pain, urinary frequency, urinary retention, voiding eight times per day, pelvic pain on right side, tender to palpation at device site, pressure at the anterior vaginal area, pushing into vagina, dyspareunia, tight device, dysuria, urethra right side tenderness, pain over area of device release, and burning, sharp, heavy pain in vagina when working.Patient had an urgent care visit for bladder pain, urgency and treated with an intravenous ceftriaxone.Patient on suppressive macrobid for recurrent urinary tract infections.Patient experienced yeast infection, mild burning at opening of vagina posteriorly, right groin pain, spastic pelvic floor syndrome, device palpable vaginally, severe right groin pain, soreness in the right labia, dull constant pain in perineal area, and an unspecified emergency department visit.Exams noted palpated device or stitches on anterior wall and at apex of vagina, pain was right obturator primarily but high tone in entire pelvic floor levator ani muscles, and sharp pain with palpation of site of obturator device going into obturator canal.Patient had explantation of device, total vaginal hysterectomy, right salpingectomy, anterior and posterior colporrhaphy, perineorrhaphy, and cystoscopy.Intraoperative findings noted the remainder of the device on the left side was left as it was off tension and the patient had no pain on that side.Only the uterus, cervix, and right fallopian tube were sent to pathology.Patient had another explantation of the device.Pathology noted the distinct mesh material was not grossly identified.The right groin possible device measured 0.9 x 0.4 x 0.3 cm and benign fibroconnective tissue.The left vaginal possible device measured 1 x 0.5 x 0.2 cm and 1 x 0.5 x 0.2 cm and benign fibroconnective tissue.

• 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: 15779556
• MDR Text Key: 303534220
• Report Number: 2125050-2022-01240
• 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: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6820292
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2022
• Date Device Manufactured: 07/30/2019
• 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: 53 YR