MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS® RETROPUBIC SLING SYSTEM; SURGICAL MESH

Model Number 5195612400

Device Problem Degraded (1153)

Patient Problems Adhesion(s) (1695); Micturition Urgency (1871); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Numbness (2415); Obstruction/Occlusion (2422); Hematuria (2558); Dysuria (2684); Constipation (3274); Kidney Infection (4502); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Genital Bleeding (4507); Sexual Dysfunction (4510); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)

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, the legal representative stated the patient with this device experienced irritation or injury to muscles, adhesions and scar tissue, inflammation, pulled or compressed nerves thereby impairing sexual function and mobility, bowel and bladder dysfunction, chronic pelvic pain and chronic groin pain.Device was explanted and interoperative findings included chronic inflammation.Device was degraded upon explant.The patient developed multiple medical conditions which includes pain with sitting, tailbone pain, de novo dyspareunia, anorectal pain, painful bladder filling, constipation, inability to wear close fitting pants, clitoral numbness, limited sitting tolerance, dysuria, perineal pain, de novo urinary urgency without objective retention, requiring a kelly plication, partial bladder outlet obstruction, and stress incontinence.The patient has undergone medical treatments and surgical procedures related to the device.

Event Description

Additional information received on 3/9/2023 states that beginning 11/28/2018 extending through 2/19/2021 at one or more times the patient experienced the following symptoms: urinary tract infections with hematuria, recurrent bright red bleeding with clots, urinary urgency, sthick/yellow mucus discharge, and sharp abdominal pain.

Event Description

Additional information was reported to coloplast, though not verified.Through (b)(6) 2021 to (b)(6) 2023 the patient experienced urinary tract infections, vaginal mesh erosion, abdominal / pelvic/ peroneal pain and nephritis / sepsis.

• Brand Name: SUPRIS® RETROPUBIC 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: 15391642
• MDR Text Key: 299573452
• Report Number: 2125050-2022-00888
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K111233
• 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: 03/14/2023

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 Model Number: 5195612400
• Device Catalogue Number: 519561
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/14/2023
• 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: 45 YR
• Patient Sex: Female