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

Model Number 5195622400

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Fever (1858); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Intermenstrual Bleeding (2665); Dysuria (2684); Dyspareunia (4505); 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, legal representative stated the patient with this device experienced dyspareunia, pain, felt erosion laterally, patient's partner felt sharp foreign body during intercourse, dysuria, small amounts of yellow discharge, vaginal tenderness, vaginal discomfort, mild spotting, vulvodynia, urinary urgency, urge incontinence, urinary frequency, stress urinary incontinence confirmed with urodynamics, vaginitis, menorrhagia, intrinsic sphincter deficiency.Patient had implantation of an unknown device under general anesthesia.Patient underwent a total laparoscopic hysterectomy for markedly enlarged fibroid uterus, bilateral salpingectomy, left ovarian cystectomy, uterosacral ligament vault colpopexy, ureterolysis (unknown device removal), device urethropexy, and cystoscopy under general anesthesia.Intraoperative findings noted the previously placed device was very distally displaced and banded, and an estimated blood loss of 150 ml.Pathology report for previous unknown device noted explantation of vaginal wall device, fibrosis and foreign body type reaction to birefringent foreign debris, gross examination of foreign body, vaginal wall device was sent in formalin and noted as a mesh-like white synthetic foreign object with attached membranous pink tissues, measuring 1.6 x 0.6 x 0.1 cm.Patient had an emergency department visit for postoperative fever and noted the postoperative fever developed 1 day after discharge from the hospital.Urine culture was 20k strep.Patient had an emergency department visit for a urinary tract infection with e.Coli.Patient had a retroperitoneal ultrasound performed for history of urinary tract infections; results were negative.A physical exam found tenderness directly under the urethra and clear point tenderness at the site of device erosion into the vagina.Patient had partial device explantation for midurethral exposed device under general anesthesia.The pathology report noted a diagnosis of the vaginal wall excisional biopsy was benign non-keratinizing squamous mucosa with chronic inflammation.Labeled exposure of vaginal wall device and epithelial tissue measuring 2.1 x 0.7 cm and also multiple device-appearing material measuring 2.0 x 0.6 cm.Patient had a urine analysis positive for leukocytes with few bacteria noted on micro exam.A vaginal swab was positive for moderate beta hemolytic streptococcus group b.An exam noted minimal tenderness and clear 1-2 cm erosion laterally on the left with tenderness.Patient had a partial explantation of exposed device under general anesthesia.Lateral device erosion was located on the left anterior fornix.Pathology reported noted vaginal mucosa with chronic inflammation, granulation tissue and reactive changes in the squamous mucosa, formalin labeled vaginal device in four tan-brown tissue fragments measuring 0.4 x 0.3 x 0.2 cm in aggregate and a device measuring 1.0 x 1.0 x 0.1 cm.

• 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: 15601370
• MDR Text Key: 301719938
• Report Number: 2125050-2022-01072
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932490016
• UDI-Public: 05708932490016
• 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
• Report Date: 10/13/2022

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: 03/31/2022
• Device Model Number: 5195622400
• Device Catalogue Number: 519562
• Device Lot Number: 5857396
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/13/2022
• Date Device Manufactured: 08/25/2017
• 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: 52 YR