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

Model Number 5195501000

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Burning Sensation (2146); Abdominal Cramps (2543); Neuralgia (4413); Dyspareunia (4505); Genital Bleeding (4507); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced vaginal bleeding, 1.0 x 0.5 cm irregular palpable non-tender mid vaginal mass at 11:00 that is black, rough and rubbery to touch, dyspareunia since 2012, vaginal irritation, lower abdominal cramping, groin pain, bloody vaginal discharge, intercourse impossible due to dyspareunia, shooting pain in right thigh, on self-exam patient felt sharp edge of foreign material inside her vagina.Patient also experienced sharp vaginal pain, intense vaginal burning and itching, vaginal exam was very painful, pelvic pain that is significantly worse with sitting and patient has hypersensitivity to underwear.Patient is afraid to even attempt intercourse due to fear of pain and fear of partner being injured by sharp edge of device, spastic pelvic floor syndrome, obturator neuralgia, pudendal neuralgia, significant tenderness of bilateral pubococcygeus muscles, and visible erosion of lower edge of device about 2 cm to right of the urethra.The patient has a plan for complete removal of entire device, bilateral pudendal nerve block, botox injection to pelvic floor muscles, robotic assisted laparoscopic burch procedure, and cystoscopy.

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.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15738896
• MDR Text Key: 303134669
• Report Number: 2125050-2022-01195
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 11/04/2022

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: 5195501000
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/04/2022
• 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 Age: 61 YR