MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195501000

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

Patient Problems Bacterial Infection (1735); Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Stenosis (2263); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Genital Bleeding (4507)

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 patient with this device experienced dysuria, minimal vaginal stenosis, bloody discharge, gradual onset sharp pelvic and vaginal pain that worsens with motion and intercourse, partner reported penile pain with intercourse and penile abrasion, intercourse tolerable with use of a condom, bacteria vaginosis, and recurrent urinary tract infections.Patient had possible device erosion visualized on anterior vaginal introitus, hematuria, positive urine culture for group b beta hemolytic strep, and previously diagnosed vaginal device erosion.Patient had partial explantation of device with vaginal tissue trimming / repair, diagnostic laparoscopy, and bilateral salpingectomy with left hydrosalpinx removal.Intraoperative findings found visualized device seen horizontally ~2 cm wide x 0.5 cm high.Also reported, urinary infection, dysuria, nocturnal enuresis, vaginal discharge, and patient unable to have intercourse due to pelvic surgery and bladder problems which lead to a stressful sexual relationship with spouse.Anterior erosion found with exam and partial scissor explantation of small amount of device from anterior vagina was completed in office.Bilateral anterior device erosion found with exam and partial scissor explantation of device from bilateral anterior vagina was completed in office.Device visualized lateral to urethra bilaterally on exam and vaginal tissue covered the blunt ends of the device and the device protruded into the vaginal cavity.Unable to trim device in office without causing significant bleeding, patient had partial explantation of the device.Interoperative findings found a small area of device protruding from the superior left side of the urethra.

• Brand Name: ARIS TRANSOBTURATOR KIT
• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15151881
• MDR Text Key: 297132413
• Report Number: 2125050-2022-00749
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5195501000
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2022
• 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