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

Model Number 5195512400

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Perforation (2001); Scar Tissue (2060); Dyspareunia (4505); Genital Bleeding (4507)

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 complications with placing mesh including blood in bladder due to perforation of the bladder on the lateral right column.Took out sling and performed reinstallation with positive results on repeat cystoscopy.Subsequently, the patient experienced vaginal pain, pain with intercourse, muscular groin pain, leg pain, foreign material in vagina and urethral scarring.Removal of this vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus muscles, anterior colporrhaphy.This was a very difficult surgery due to folding of the mesh and the scarring from previous surgery and the dissection required to remove the mesh from the groins that was very deeply implanted as well as in the bladder wall on the right.The lateral mesh arms also had a vertical trajectory from lateral to medial.

• 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: 12577679
• MDR Text Key: 274774534
• Report Number: 2125050-2021-01443
• Device Sequence Number: 1
• Product Code: FHW
• 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
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 6556223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Date Device Manufactured: 11/07/2018
• 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: 51 YR