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

Model Number 5195512400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Internal Organ Perforation (1987); Pain (1994); Urinary Tract Infection (2120); Uterine Perforation (2121); Post Operative Wound Infection (2446); Dyspareunia (4505); Genital Bleeding (4507); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/14/2020

Event Type  Injury  

Event Description

Article citation: armstrong, k.L., a.M.Modest, and p.L.Rosenblatt, laparoscopic cerclage sacrohysteropexy: comparing a novel technique for sacrohysteropexy to traditional supracervical hysterectomy and sacrocervicopexy.Female pelvic medicine & reconstructive surgery, 2021.27(2): p.E315-e320.Doi: 10.1097/spv.0000000000000917.According to the available information, there were three intraoperative complications in the laparoscopic cerclage sacrohysteropexy (lcsh) cohort: 1 uterine perforation on placement of uterine manipulator, 1 gastric perforation on abdominal entry, and 1 cystotomy.There were 6 postoperative complications in the lcsh cohort.The complications included 2 wound infections, 2 patients with recurrent urinary tract infections (utis), 1 patient with vaginal bleeding, and 1 with a hematoma at site of perineorrhaphy.Post operative complications included pelvic pain, dyspareunia, voiding dysfunction, or bowel dysfunction, however, it was unclear if these pertained to the lsh cohort or to the lcsh cohort.

Manufacturer Narrative

(b)(4).Should additional information 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12774579
• MDR Text Key: 284834719
• Report Number: 2125050-2021-01633
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• 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): Other
• Patient Age: 60 YR
• Patient Sex: Female