MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX POSTERIOR; SURGICAL MESH

Model Number 5014602400

Device Problem Migration (4003)

Patient Problems Erosion (1750); Cyst(s) (1800); Micturition Urgency (1871); Muscle Weakness (1967); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced worsening pelvic pain, difficulty with voiding, recurrent urinary tract infections and urge incontinence.Patient had explantation and revision of the device, vaginal paravaginal repair with xenograft, posterior repair and perineorrhaphy, cystourethroscopy, and excision of labial cyst under general anesthesia.Intraoperative findings noted a grade 2-3 cystocele, bilateral paravaginal defects and weakened pelvic tissue.Patient was noted to have a stage ii rectocele after portions of the device were explanted.On exam, a 5 mm linear device exposure on the posterior apical wall was noted.

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: RESTORELLE DIRECTFIX POSTERIOR
• 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: 16112103
• MDR Text Key: 306793950
• Report Number: 2125050-2022-01467
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 05708932484084
• UDI-Public: 05708932484084
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2019
• Device Model Number: 5014602400
• Device Catalogue Number: 501460
• Device Lot Number: 5361822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2022
• Date Device Manufactured: 12/15/2016
• 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: 73 YR