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

Model Number 5195501400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Exposure to Body Fluids (1745); Pain (1994); Post Operative Wound Infection (2446); Dyspareunia (4505); Genital Bleeding (4507)

Event Date 02/26/2007

Event Type  Injury  

Manufacturer Narrative

According to the available information, the patient's legal representative severe pain with daily activities and intercourse, chronic urinary tract infections as well as vaginal bleeding and reoccurring stress incontinence, mesh exposure.Aris was implanted on (b)(6) 2007.Corrective action: management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to the reported complaints are captured in the product risk documentation.Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device not returned.

Event Description

As reported to coloplast, though not verified, add'l info rec'd 4/11/2021: on (b)(6) 2007: recurrent sui.On (b)(6) 2016: sui, pelvic pain, palpable aris tot migration to the proximal anterior segment under the cephalad portion of bladder base.Excision of aris, anterior colporrhaphy, non-coloplast implant, cystourethroscopy under general anesthesia.No other adverse patient effects were reported.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12418479
• MDR Text Key: 271752681
• Report Number: 2125050-2021-01256
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195501400
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 MO