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

Model Number 5195512400

Device Problems Material Erosion (1214); Material Fragmentation (1261)

Patient Problems Erosion (1750); Fever (1858); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Chills (2191); Myalgia (2238); Ulcer (2274); Hematuria (2558); Dysuria (2684); Fibrosis (3167); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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, it was reported that the patient experienced ongoing bleeding, urinary issues, problems with intercourse, mesh exposure in vagina.Partial mesh explant with placement of an autologous pubofascial sling.Currently, plaintiff continues to experience problems, groin pain, pelvic pain, vaginal pain, painful intercourse and urinary problems.

Manufacturer Narrative

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

Additional information received on 6/6/2022 reported that the patient experienced urinary incontinence, a vaginal ulcer, acute cystitis, chronic inflammation, fibrosis, and eroded vaginal tissue.The patient underwent an excision of the device under general anesthesia on (b)(6) 2019.

Manufacturer Narrative

Correction: the previously submitted h6 annex a code a040503 "material erosion" was applied in error.

Event Description

Additional information received further reported that vaginal tissue showed inflammation and fibrosis with a fragment of foreign material consistent with mesh.The patient experienced dysuria, fever, chills, nausea, and was diagnosed with a urinary tract infection.The patient also experienced retention, levator myalgia, urethral hypermobility, and microscopic hematuria.Physical exam noted a small area (0.5 centimeters) of mesh erosion on the right aspect of the anterior vaginal wall.Computed tomography (ct) urogram was negative for any obstructive uropathy or filling defects.The patient was started on detrol and cipro.On 27jan2020, the patient¿s urinary retention, dyspareunia, stress urinary incontinence, and vaginal bleeding had resolved.

• 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: 11806726
• MDR Text Key: 249996631
• Report Number: 2125050-2021-00490
• 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
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2022
• 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 Sex: Female