MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBUTRATOR; OTN

Model Number UR31012022

Device Problem Scratched Material (3020)

Patient Problems Irritation (1941); Complaint, Ill-Defined (2331)

Event Date 08/20/2014

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with aris mesh.Later the patient experienced tape exposure, had irritation and was aware of a rough structure in the vagina.A surgical removal of exposed portion of the tape was performed.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device not returned.

• Brand Name: ARIS TRANS-OBUTRATOR
• Type of Device: OTN
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlebaek 3050, dk
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 w. river road n.; minneapolis MN 55411
• Manufacturer Contact: angela kilian-head of ra ; 1601 w. river road n.; minneapolis, MN 55411 ; 6122874236
• MDR Report Key: 4093989
• MDR Text Key: 16849376
• Report Number: 2125050-2014-00399
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/16/2014

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: Other
• Device Model Number: UR31012022
• Device Catalogue Number: UR31012022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other