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

Model Number UR31012022

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Scar Tissue (2060); Skin Erosion (2075); Dyspareunia (4505)

Event Type  Injury  

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.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced chronic pelvic pain and frequency of urine since the device was implanted.The patient has had chronic lumbosacral pain, pain in pubic bone as well as pain on palpation of the sling.Pain near her pubic bone on the right as well as deep in the vagina.There was no sign of erosion of the mesh on physical exam, despite continued perineal pain as well as pain in both legs post tot placement.Immobile, difficulty walking and going up stairs.Cystoscopy performed during which vaginal atrophy was noted, however no extrusion of the mesh was noted during exam.Subsequently, the patient continued to experience vaginal pain, pain with intercourse, muscular groin pain, leg pain, foreign material in vagina, urethral scarring.Therefore, removal of this vaginal sling was performed.At that time, removal of vulvar mesh was performed with exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus muscles, and anterior colporrhaphy was performed.

• 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: 12491986
• MDR Text Key: 272177607
• Report Number: 2125050-2021-01339
• 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: 09/17/2021

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: UR31012022
• Device Catalogue Number: UR3101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/17/2021
• 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: 71 YR