MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 519650

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

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558); Dyspareunia (4505)

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 recurrent urinary tract infections, feeling a ¿nodularity¿ during intercourse, defecate tori dysfunction, pelvic floor muscle spasticity, dyspareunia, myofascial abdominal wall pain, recurrent hematuria, compromised vaginal caliber, exquisite tenderness to palpation of the obturators internus on the right side, light yellow vaginal discharge, cystoscopy, high grade anorectal motility study suggests a possible evacuation disorder, urinary hesitancy, needs to strain to void, loss of consortium with spouse, pelvic floor tension myalgia, discomfort with direct palpation of the device, stress urinary incontinence, high-tone pelvic floor dysfunction, and a cmg study for residual stress incontinence.Patient had pelvic floor therapy for pelvic floor pain and myalgia, dyspareunia, and urge urinary incontinence.Patient had explantation of the device, explantation of another manufacturer's device, cystoscopy, suprapubic catheter placement, rectus fascia harvest, pubovaginal device, and cystourethropexy with autologous rectus fascia.Intraoperative findings noted the patient had evidence of separation of the spongiosum in the midline scar and thickened tissue to either side of the urethra consistent with previous surgery.The mini device was in a much more distal location.One of the anchors did remain somewhat embedded in the obturator fascia.The right side was removed as much as possible, the entire anchor was removed on the left.Physical examination notes separation of the vaginal mucosa along the urethra and mild urethral discomfort.Patient had a post-operative abdominal wall hematoma and had drainage of postoperative abdominal wall hematoma with a negative fluid culture.Patient had an evacuation of an anterior abdominal wall hematoma, drain placement and an excision of the seroma cavity.Pathology report noted soft tissue, anterior abdominal wall seroma sac, excision of reactive fibrosis with granulation tissue and giant cell reaction, consistent with seroma cavity.Measuring 5x5 x 4.3 x 3.0 cm.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17788108
• MDR Text Key: 323916141
• Report Number: 2125050-2023-01157
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/14/2022
• Device Catalogue Number: 519650
• Device Lot Number: 6997457_5196502400
• 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: 49 YR