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 Device Appears to Trigger Rejection (1524)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Retention (2119); Prolapse (2475); 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 dyspareunia, unable to urinate, vaginal pain, cystocele, enterocele, vaginal foreign body, voiding dysfunction, recurrent incontinence, complete vaginal vault prolapse, cystourethrocele, rectal intussusception, erythematous vaginal tissue at introitus, palpable device present at approximate 2 inches into vagina at right posterior and lateral wall, husband feels a poking sensation during intercourse, vaginal exam noted bluish material either suture or device material, and device exposure.The patient had removal of vaginal foreign body (prolene suture) under unknown anesthesia.Patient had laparoscopic robotic assisted abdominal graft revision, abdominal enterocele repair, release of sacrospinous fixation, vaginal device revision, vaginal graft revision, repair of bladder laceration, anterior repair, cystoscopy and urethrolysis under general anesthesia.Patient also had a robotic assisted laparoscopic sacrocolpopexy, device explanation, enterocele repair, cystoscopy, fascia harvest for sacrocolpopexy and abdominal graft revision under general anesthesia.

• 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: 17696692
• MDR Text Key: 322799140
• Report Number: 2125050-2023-01092
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2023

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 Catalogue Number: 519650
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2023
• 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: 54 YR