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

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Itching Sensation (1943); Pain (1994); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Hematuria (2558); Dysuria (2684); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, patient's legal representative stated urinary tract infections, urinary retention, pain, hematuria, urgency, dysuria.The patient also reported: a small amount of urinary leakage with intercourse, abdominal swelling, abdominal/suprapubic pain, urinary frequency, right flank pain, sui with sneezing, incomplete bladder emptying, nocturia, hesitancy/ intermittency/straining, double voiding, abdominal bloating/vaginal itching/thick vaginal discharge, aris palpable below the urethra but not tender, back pain.

• 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: sarah o'gara ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10059287
• MDR Text Key: 191137414
• Report Number: 2125050-2020-00384
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2020
• 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): Other