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

Model Number 5014502400

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Pain (1994); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, patient's legal representative stated severe pain, vaginal prolapse, urinary incontinence, physical deformity, the loss of the ability to perform sexually, serious and permanent physical and emotional injuries, erosion of the vaginal wall and other tissues, infection, permanent and substantial physical deformity.A revision surgery occurred to excise and remove a portion of the restorelle mesh.Patient also had restorelle directfix posterior and altis single incision sling system reported under 2125050-2020-00704 and 2125050-2020-00706.

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint, the device not being returned for evaluation and the lot number not being provided, 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

As reported to coloplast, though not verified, additional information received on (b)(6)2021.(b)(6)2015: recurrent sui, stage iii pop.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10410672
• MDR Text Key: 203139535
• Report Number: 2125050-2020-00705
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention