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

Model Number FPH-MESH-UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Pain (1994); Skin Erosion (2075); Urinary Frequency (2275); Prolapse (2475); Fluid Discharge (2686); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced bacterial vaginosis, device exposure, mixed urinary incontinence, increased discharge, nocturia, urinary urgency, urinary frequency, vaginal bleeding occasionally when wiping, and grade iii cystocele and uterine prolapse.It was noted that patient experienced symptoms related to a urinary tract infection that included burning with urination and pain in the back and side.Significant other reported that he felt something poking him during sexual activity.Procedures included laparoscopic supracervical hysterectomy with sacrocolpopexy using y-graft, bilateral salpingectomy, adhesiolysis, implantation of another manufacturers device and excision of anterior vaginal wall device.Intraoperative findings from the procedures included device erosion to the anterior vaginal wall, anterior wall adhesions.The left fallopian tube was adherent to the bowel.Pathology follow up for uterus and tubes.

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.

• 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: 14251251
• MDR Text Key: 290391291
• Report Number: 2125050-2022-00440
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FPH-MESH-UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• 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