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

Model Number 5195512400

Device Problems Material Erosion (1214); Material Twisted/Bent (2981)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.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, legal representative stated the patient with this device experienced mesh erosion, vaginal pain, pelvic pain, dyspareunia thigh pain, flank pain, dysuria, infection, bleeding, frequency, urgency, urge incontinence, recurrent stress urinary incontinence (sui), and mixed incontinence.A portion of the mesh was excised and removed ((b)(6) 2020), and then again, a portion of the mesh was excised and removed ((b)(6) 2020).

Manufacturer Narrative

This follow-up mdr is created to document the additional event information received for record 2125050-2022-00267.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information reported to coloplast, though not verified, legal representative stated that the patient also experienced right thigh pain, pain when ambulating and when placing pressure on the right leg, increased pain in the right lower abdomen that radiated to the right thigh, pain rating 8 out of 10, pain in right vaginal area radiating to the thigh, vaginal pain that is worse at night, palpable suture present to the right of the urethral body, left sided discomfort and exposed, twisted, tender midureteral foreign body.Patient can feel the device and has to change positions to void.On exam, device exposure noted on right side of urethral body approximately 2 mm in size.Another exam found a small area of exposed device.Patient had a robotic assisted device revision, laparoscopic abdominal foreign body revision, laparoscopic burch procedure, and ureterolysis ((b)(6) 2020).Pathology diagnosis from procedures: abdominal foreign body with chronic inflammation, foreign body reaction and a removed device that measured 21.5 x 1.0 x 0.2 cm.

Event Description

Additional information received on 10/7/2022 as follows: (b)(6) 2021 patient experienced a urinary tract infection.(b)(6) 2021 patient experiencing hematuria.

Event Description

Additional information received on (b)(6) 2023 indicates that the patient was also experiencing hematuria.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13792792
• MDR Text Key: 287343036
• Report Number: 2125050-2022-00267
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/18/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 4909022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 03/30/2022; 08/08/2022; 10/07/2022; 04/10/2023
• Supplement Dates FDA Received: 04/06/2022; 09/03/2022; 10/17/2022; 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female