MAUDE Adverse Event Report: COLOPLAST CORP RESTORELLE DIRECT FIX POSTERIOR MESH; SURGICAL MESH

Model Number 5012901400

Device Problems Wrinkled (2614); Extrusion (2934)

Patient Problems Erosion (1750); Scar Tissue (2060); Therapeutic Response, Decreased (2271)

Event Date 01/02/2013

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device was not explanted or returned.

Event Description

As reported to coloplast though not verified, patient was implanted with restorelle direct fix posterior mesh.Later the patient experienced exposed mesh on the right side under her urethra; recurrent rectocele and significant scar along posterior wall; restorelle mesh was not attached well laterally or distally and was wrinkled.A partial explant was performed; excision of restorelle vaginal mesh posteriorly was performed with a rectocele repair and cystoscopy.

• Brand Name: RESTORELLE DIRECT FIX POSTERIOR MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west river road north; minneapolis MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: janell colley ; 1601 west river road north; minneapolis, MN 55411 ; 6122874237
• MDR Report Key: 5025554
• MDR Text Key: 23907507
• Report Number: 2125050-2015-00085
• Device Sequence Number: 1
• Product Code: OTP
• 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
• Report Date: 07/24/2015

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: Physician
• Device Model Number: 5012901400
• Device Lot Number: 10040601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR