MAUDE Adverse Event Report: COLOPLAST A/S ARIS (SLING ONLY); SURGICAL MESH

Model Number 5195101000

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395)

Patient Problems Bacterial Infection (1735); Erosion (1750); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Vaginal Mucosa Damage (2124); Distress (2329); Dysuria (2684)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced urge incontinence, clear discharge, pruritis, urinary analysis with small leukocyte esterase, voiding difficulties, painful urination, urinary retention, urinary frequency, bacterial vaginosis, vaginal mucosa with lichenoid chronic inflammation, pain and suffering.Patient noticed migration of device into her vaginal region within 6 months of being implanted.

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 (SLING ONLY)
• 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: 15627976
• MDR Text Key: 301972825
• Report Number: 2125050-2022-01095
• 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,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5195101000
• Device Catalogue Number: 519510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2022
• 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
• Patient Sex: Female