MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBTURATOR; SURGICAL MESH

Model Number 5195501000

Device Problem Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 12/20/2015

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Otn exemption # (b)(4) total number of events summarized - 55.Aris - 43, supris - 8, omnisure - 2, minitape - 2.

Event Description

As reported to coloplast though not verified, patient's legal representative stated stress incontinence, fecal incontinence, urge incontinence, revision/removal of vaginal mesh- 3 mm plug of exposed mesh in right posterior fourchette with overlying granulation tissue, vaginal bleeding, and back pain.

• Brand Name: ARIS TRANS-OBTURATOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6354361
• MDR Text Key: 68180642
• Report Number: 2125050-2017-00029
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K053296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 02/23/2017

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?: No
• Device Operator: Physician
• Device Model Number: 5195501000
• Device Catalogue Number: 5195501000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 02/23/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR