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

Model Number 5195512400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Injury (2348); Deformity/ Disfigurement (2360); Fluid Discharge (2686); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, patient's legal representative stated severe pain with daily activities and intercourse requiring additional medical care and surgical removal of the sling, severe emotional pain and injury and has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, discharge, and multiple corrective surgeries, operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of female genitalia, urinary incontinence, physical deformity, and the loss of the ability to perform sexually, erosion of the vaginal wall and other tissues, physical pain.

Event Description

Additional information received further reported that in (b)(6) 2016, separation of the vaginal incision occurred, with a 2-centimeter exposure of midureteral sling mesh.Revision of the previous midureteral sling and closure of vaginal incision took place under unspecified anesthesia.In (b)(6) 2016, separation of midureteral mesh and sling incision in midportion of posterior urethra occurred, with exposure of mesh.Revision of the midureteral sling took place under unspecified anesthesia.In (b)(6) 2016, vaginal mesh exposure and wound separation recurred.There was complete separation of anterior vaginal incision.Excision of the aris sling and cystoscopy took place under unspecified anesthesia.

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; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10351469
• MDR Text Key: 201507150
• Report Number: 2125050-2020-00600
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5195512400
• Device Lot Number: 4615516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female