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

Model Number 5196502400

Device Problem Migration (4003)

Patient Problems Bacterial Infection (1735); Erosion (1750); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Sepsis (2067); Urinary Retention (2119); Distress (2329); Intermenstrual Bleeding (2665); Dysuria (2684); Kidney Infection (4502); Unspecified Kidney or Urinary Problem (4503); 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 bothersome sexual intercourse for spouse, spouse states he feels a brillo pad sensation, device erosion through vagina mostly right posterior area, vaginal pain, feels residual device in vagina causing dyspareunia for herself, bilateral flank pain, urinary retention, urinary hesitancy, low intermittent stream, positional voiding and must lean forward to fully empty bladder, valsalva voiding, chronic cystitis, sensation of incomplete bladder emptying, postcoital vaginal bleeding and discharge, bladder pain, chronic and intermittent dysuria.Patient had an emergency department visit and hospital admission for e.Coli, urosepsis, pyelonephritis, acute on chronic kidney disease.Patient had a subsequent emergency department visit for mixed gram-positive flora and pyelonephritis.Patient had a pelvic examination under anesthesia, cystoscopy and a partial explantation of the device.Patient had an exam that noted a 1 cm right anterior vaginal wall device erosion.She had a urodynamics test that noted incomplete bladder emptying.Patient had a second examination and partial explantation of the device with attached suture, excision of scarred vaginal mucosa; cystocele, rectocele, and enterocele repair; soft tissue reconstruction of the bladder neck, trimming of excess vaginal mucosa, and cystoscopy under anesthesia.

Event Description

Additional information received on 6/28/2023 states the patient has experienced significant mental and physical pain and suffering and has sustained permanent injury.

• 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: 15708318
• MDR Text Key: 302774773
• Report Number: 2125050-2022-01180
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6759282
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2023
• Date Device Manufactured: 06/25/2019
• 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: 67 YR
• Patient Sex: Female