MAUDE Adverse Event Report: RESTORELLE Y CONTOUR; SURGICAL MESH

Model Number 5015202400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Muscle Spasm(s) (1966); Nerve Damage (1979); Pain (1994); Swelling (2091); Urinary Retention (2119); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Numbness (2415); Prolapse (2475); Dysuria (2684); No Information (3190); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

This mdr report is to follow up on record id (b)(4), originally reported in the 2016 asr report for december 2015-january 2016, under product code oto / exemption # e2014015.(b)(4).The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This mdr report is to follow up on record id (b)(4), originally reported in the 2016 asr report for december 2015-january 2016, under product code oto / exemption # e2014015.As reported to coloplast though not verified, the patient's legal representative stated pelvic pressure, sharp vaginal twinges, frequency, groin pain, difficult bm's, rectocele, swelling, poking sensation in urethra, groin pain, dysuria, dyspareunia, incontinence, incomplete bladder emptying, recurrent cystocele and rectocele, mesh exposure.On (b)(6) 2014 - excision of restorelle mesh, leakage of urine with intercourse, burning introitus, difficulty with bm's, bulge in vagina with stooling, sciatic and left buttock pain, numbness to both thighs, tenderness at palpation, discomfort, coccygeus and iliococcygeal spasms, chronic constipation.On (b)(6) 2015 revision of mesh.On (b)(6) 2016 revision of mesh.On (b)(6) 2018 - pudendal neuralgia with significant right sided pelvic pain and urge incontinence.

• Brand Name: RESTORELLE Y CONTOUR
• Type of Device: SURGICAL MESH
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, mn ; 2874138
• MDR Report Key: 10324023
• MDR Text Key: 208329375
• Report Number: 2125050-2020-00564
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5015202400
• Device Catalogue Number: 501520
• Device Lot Number: 3698624
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR