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

Model Number 5195511400

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); Deformity/ Disfigurement (2360); Prolapse (2475); No Code Available (3191)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot number was reviewed for complaint trend, nonconforming report and capa review.Devices met specification prior to release and no trends were noted.

Event Description

As reported to coloplast though not verified, the patient's legal representative stated severe pain with daily activities and intercourse, urethral pain and abdominal pain, exposure, vagina prolapse, urinary incontinence, physical deformity and the loss of the ability to perform sexually.Mesh was excised and removed.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10040434
• MDR Text Key: 190381796
• Report Number: 2125050-2020-00368
• 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: other
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195511400
• Device Catalogue Number: 519551
• Device Lot Number: 2042092
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention