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

Model Number 5195511400

Device Problems Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521)

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

According to the available information, though not verified the patient experienced pelvic cramping, urinary urgency and frequency, urethral pressure, possible low-grade uti, pain, possible erosion, mesh extrusion, and a bladder lesion.

• 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: 12728199
• MDR Text Key: 279290224
• Report Number: 2125050-2021-01578
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5195511400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 40 YR