MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y SHAPED 24X4CM; SURGICAL MESH

Model Number 5014202400

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Dysuria (2684); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 patient experienced infections, vaginitis, pain, painful urination and incontinence after implantation of restorelle mesh.The patient was told her problems resulted from a suspicious vaginal lesion, and had surgery on (b)(6) 2014, to correct the lesion.However, her problems persisted.The patient was then told her problems resulted from persistent vaginitis, and had surgery on (b)(6) 2016, to correct that issue.However, her problems persisted.The surgeon attempted to remove the vaginal mesh on (b)(6) 2018, but was unsuccessful as fragments of the mesh remain embedded inside the patient's vaginal wall.The (b)(6) 2018 post-operative report showed exposure of the foreign body (mesh) plus erosion of the mesh into the muscular wall of the patient's vagina with probable infection-laden mesh.Also, the report showed dense fibrotic adhesions of the bladder to the cervix and anterior vaginal wall.

Manufacturer Narrative

This follow-up mdr is created to document the additional/corrected device information and 510k number.The lot number was reviewed for complaint trend, nonconforming report and capa review.Devices met specifications prior to release and no trends were noted coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Manufacturer Narrative

This follow-up mdr is created to document the additional patient date of birth reported.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information and explant date.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information reported to coloplast though not verified: the medical record on 7/24/18 indicated that patient had another vaginal repair and is struggling with urinary incontinence and very stressed about it.

Event Description

On (b)(6) 2016 - excision of vaginal polyp with granulation tissue, exploration of submucosal tract note.

• Brand Name: RESTORELLE Y SHAPED 24X4CM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8061599
• MDR Text Key: 126919303
• Report Number: 2125050-2018-00790
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K112322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5014202400
• Device Catalogue Number: 501420
• Device Lot Number: 3227904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other