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

Model Number 5014201400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Emotional Changes (1831); Pain (1994); Skin Erosion (2075); Urinary Retention (2119); Hernia (2240); 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.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 these patient with this device experienced surgical mesh erosion, cystocele, rectocele, vaginal vault prolapse, voiding dysfunction, urinary retention, uv (urethrovesical) angle ~0 degrees, partial excision of eroded surgical mesh, vaginal mucosa trimming/biopsy, paravaginal defect repair, urethrolysis, anterior/posterior colporrhaphy with sacrospinous fixation, perineoplasty, cystoscopy x 2.Intraoperative findings included surgical mesh erosion at vaginal apex with visible sutures, left paravaginal defect (repaired), immobile urethra (mobilized to ~20-30 degrees).Subsequently, approx.5 weeks postop the patient stated that she noted a popping sensation with straining followed by a progressive bulge, improved urinary flow, no further issues with urinary retention.1/3/2012- claimant states vaginal bulge is worsening and impacting her quality of life, using vaginal estrogen.In-office cystoscopy revealed normal, pvr 50 ml.Additionally, anterior vaginal wall prolapse to hymenal ring with valsalva, apex/posterior vaginal wall well supported, no evidence of mesh erosion, the patient refused conservative therapy, and adamantly stated she would like to proceed with an additional mesh implant despite history of prior mesh erosion.So, the patient underwent a cystocele and was implanted with a competitor's product.

Event Description

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

• Brand Name: RESTORELLE Y
• 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: 12198328
• MDR Text Key: 262690012
• Report Number: 2125050-2021-00938
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5014201400
• Device Catalogue Number: 501420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 05/03/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female