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

Model Number 5196502400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erosion (1750); Fatigue (1849); Micturition Urgency (1871); Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Urinary Frequency (2275); Depression (2361); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Genital Bleeding (4507); Skin Inflammation/ Irritation (4545); Decreased Appetite (4569)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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 recurrent urinary tract infections, vaginal device erosion or exposure lateral of the midline, acute vaginitis, acute cystitis, recurrent vaginal yeast infections, vaginal bleeding, bleeding during intercourse, vaginal spotting, hematuria, bacterial vaginosis, bright red bleeding with bladder and bowel voids for three months, dyspareunia, right side device palpable and tender to touch, persistent intermittent vaginal bleeding that has an odor like feces, device palpable just right of urethra, vaginal bleeding associated with pelvic pain and dyspareunia, 1-2 cm area of exposed device on right side of midurethral sling, pain in vagina that feels like string pulling all the way to chest, pressure with urination, dysuria, bladder pressure sensation, ongoing sensation of incomplete bladder emptying, vaginal irritation/itching/burning, boyfriend feels like something is poking him during intercourse, suture palpable at vaginal cuff, and acute vulvitis with pruritus.Patient had vaginal bleeding and spotting when wiping once a month.Unclear where the source of bleeding is from.It is possibly the device irritating and resulting in bleeding.Patient had robotic assisted laparoscopic trachelectomy, lysis of adhesions, modified mccall culdoplasty, cystotomy repair times two with double layer closure, blake drain placement, and cystoscopy.Patient also had a robot undocked for device trimming and revision on the right side with defect closure times two and skin tag excision from right labium minus.Patient had intermittent vaginal and rectal irritation since surgery that required numerous courses of antibiotics and vaginal yeast infections.Patient experienced feeling down, significant fatigue, has trouble doing daily activities and needs to rest frequently, worried about things, loss of appetite and not sleeping well since surgery.Patient had an emergency department visit to hospital admission for a urinary tract infection with hematuria positive for e.Coli and extended-spectrum beta-lactamases.Patient had another emergency department visit for pyelonephritis with hematuria positive e.Coli, urinary frequency, and right flank pain.Patient had an emergency department visit for acute cystitis with hematuria positive for e.Coli, dysuria and urinary frequency.

Event Description

Additional information received reported the patient also experienced vaginal atrophy and urinary urgency problems.

• 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: 16850929
• MDR Text Key: 314350079
• Report Number: 2125050-2023-00495
• 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,Followup
• Report Date: 08/21/2023

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: 11/14/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6997457
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 08/21/2023
• Date Device Manufactured: 11/15/2019
• 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: 57 YR
• Patient Sex: Female