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

Model Number 5195512400

Device Problems Device Appears to Trigger Rejection (1524); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Foreign Body Reaction (1868); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Fluid Discharge (2686); Fibrosis (3167); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot: ak090058.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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.

Event Description

As reported to coloplast, though not verified, the patient experienced the following: radiating and persistent pain, a feeling of the sling lowering or falling, feeling as though the sling is too long on the right side, sciatic pain related to tot, difficulty walking and sitting due to pain, bladder discomfort, urinary frequency and urgency, nocturia, dyspareunia, anxiety, insomnia, restlessness, decreased appetite, and muscular tension.An mri conducted on (b)(6) 2019 noted tears and minor degradative changes to the right and left sacro-iliac joints.On (b)(6) 2019, the device was removed with exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus externus and adductor muscles, and anterior colporrhaphy under general anesthesia.The final report for that procedure noted fibrosis and patchy mild chronic inflammation, whitish/yellow discharge, and cystitis.Post-operatively, the patient experienced urinary incontinence, new right sided pain since the sling was removed, pain with urination, urgency, and stress incontinence.Ua and urine culture tested positive for 3 types of bacteria.

• 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: 12392928
• MDR Text Key: 268970727
• Report Number: 2125050-2021-01224
• 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: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

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: 5195512400
• Device Lot Number: NOT IN LIST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/31/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR