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

Model Number 5195512400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

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, the patient with this device experienced incontinence, pain with activity.The patient attended physical therapy for pain in left leg following urethropexy.Additionally, radiating vaginal pain, perineal pain worse on palpation and when moving and urge and stress incontinence.Left pelvic pain characterized by tension interior obturator and pubovaginal limiting the quality of life.Sui characterized by weak pelvic muscles.Scarring adhering on the vaginal vault.Urodynamics performed with pain felt at ureter while voiding.Vaginal scarring and adhesions, tension, continued radiating pain from pelvis to left leg.Intravaginal injections were attempted to relieve the pain, but the pain is persisting in left hip, worse in the morning.Difficulty moving left leg.Persistent atypical pain since sling was placed.Plan to do vaginal ultrasound to view the sling prior to possible removal.Frequent urination and discomfort with a full bladder.Vaginal pressure.Activities are limited.Mri of pelvis and left hip performed for pain and neuropathy.No results noted for pelvic area.Mri performed for left hip pain.Left anterior and posterior perineal fibrotic changes noted.The band appears to have adhered to the vagina causing friction on the vaginal wall and anterior rectum.

• 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: 12381252
• MDR Text Key: 268692783
• Report Number: 2125050-2021-01207
• 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
• Type of Report: Initial
• Report Date: 08/28/2021

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: Health Professional
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 6556224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/28/2021
• Is the Device Single Use?: No
• 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: 62 YR