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

Model Number 5195512400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Urinary Frequency (2275); Hematuria (2558); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, the patient with this device had an overactive bladder and received a botox injection.Approximately 6 months after the injection, she began to experience stress incontinence, vaginal bleeding, overactive bladder, nocturia, abdominal pain, hematuria, frequency and uti.

• 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: usjki jennifer kinneman ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11729201
• MDR Text Key: 261315527
• Report Number: 2125050-2021-00427
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 04/26/2021

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: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/26/2021
• 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: 48 YR