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

Model Number 5014602400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Pain (1994); Deformity/ Disfigurement (2360); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572)

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 recurrent pelvic prolapse, pelvic pain, possible defecatory dysfunction requiring surgical intervention.Surgical findings included dense omental and small bowel adhesions to the anterior abdominal wall and pelvis, adhesion of right pelvic sidewall to vagina and bowel creating a leftward displacement of the right ureter, anchor/probable titanium anchor right retroperitoneum approximating ureter, pelvic organ prolapse, left mesh arm running through vaginal apex, mesh folded over vaginal apex and proximal posterior compartment.

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

Event Description

The patient with this device experienced inter alia, severe pain with daily activities, and intercourse.The patient suffered severe emotional pain and injury inclusive of urinary incontinence, physical deformity, and the loss of ability to perform sexually.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12196743
• MDR Text Key: 262455446
• Report Number: 2125050-2021-00935
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 5014602400
• Device Catalogue Number: 501460
• Device Lot Number: 3241588
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2022
• Date Device Manufactured: 05/09/2012
• 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 Age: 77 YR
• Patient Sex: Female