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

Model Number 5195601400

Device Problems Device Appears to Trigger Rejection (1524); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Sepsis (2067); Urinary Tract Infection (2120); Discharge (2225); Fungal Infection (2419); Hematuria (2558); Blood Loss (2597); Dysuria (2684); No Information (3190)

Event Date 03/12/2013

Event Type  Injury  

Manufacturer Narrative

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for (b)(6) 2018- (b)(6) 2019.This mdr is to reflect the additional information (date of birth) to be added to the initial asr report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Event Description

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for (b)(6) 2018- (b)(6) 2019.This mdr is to reflect the additional information to be added to the initial asr report.

Event Description

Additional information, as reported to coloplast though not verified, indicated pain, uti, ovarian cyst, acute cystitis, erosion, vaginal discharge, bleeding, protruding mesh.(b)(6)2017 - removal of eroded mesh date cancelled.No records of rescheduling were provided.(b)(6) 2018 - vaginal yeast infection, uti and dysuria.(b)(6) 2019 - hospitalization for pyelonephritis, pain, sepsis due to undetermined organisms, hematuria, bmi, dilation of ureter.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk, 3050, ; DA
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10123733
• MDR Text Key: 200989208
• Report Number: 2125050-2020-00419
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5195601400
• Device Catalogue Number: 519560
• Device Lot Number: 3557238
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: Not provided; 12/21/2018
• Supplement Dates FDA Received: 07/30/2020; 09/08/2022
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female