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

Model Number 5195102400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Hematuria (2558); Dysuria (2684); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced urinary leakage, daytime urinary frequency, muscles spasms in bladder and low pelvis, dysuria, groin pain, intermittent hematuria, multiple urinary tract infections (uti), nocturia, mild vaginal pain that feels like a zinging sensation, feels like she is sitting on something, it was determined that these were complications of this implanted device.Complete removal of this device was performed with exploration of bilateral obturator space, urethrolysis with repair, left bladder wall repair, left paravaginal defect repair, anterior colporrhaphy.Intraoperative findings noted that this was a very difficult dissection (r>l) required to removal of this device from bilateral groins that was very deeply/medially implanted into the muscles and in left bladder wall, deformed/folded mesh at bladder neck, mesh in urethra with urethral scarring.Pathology report noted mesh removal with surrounding giant cells and mild chronic inflammation.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.

• 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: 13337928
• MDR Text Key: 285764635
• Report Number: 2125050-2022-00055
• Device Sequence Number: 1
• Product Code: OTN
• 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
• Report Date: 01/24/2022

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: Health Professional
• Device Model Number: 5195102400
• Device Catalogue Number: 519510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 01/24/2022
• 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: 48 YR
• Patient Sex: Female