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

Model Number 5013601400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Erosion (1750); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Prolapse (2475); Hematuria (2558); Dysuria (2684); Fecal Incontinence (4571)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced neuromuscular pain, pelvic pain, prolapse recurrence, abdominal pain, erosion, groin pain, recurrent incontinence, infection, perforation, and scarring.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.It is unknown if this device remains implanted or not.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

Additional info received on 10/28/2022 as follows: on (b)(6) 2010: restorelle ak/mpathy and prolene sutures used for cystocele repair and uteropexy, monarch/ams implant, surgi-flo application.On (b)(6) 2014: new patient visit ¿ symptomatic uti with hematuria (+) staphylococcus haemolyticus.On (b)(6) 2014: hematuria, pelvic pain.On (b)(6) 2015: in-office cystoscopy ¿ squamous metaplasia with urethra prominence at membranous urethra likely related to prior sling (monarch), bladder sensitivity to filling, otherwise normal.03/09/2015: hematuria, pelvic pain.On (b)(6) 2016: dysuria.On (b)(6) 2016: claimant requesting medication for possible uti.On (b)(6) 2017: dysuria.On (b)(6) 2017: clamant states she has hematuria.(b)(6) 2018 indication: microscopic hematuria.On (b)(6) 2019: uti with hematuria (+) e.Coli.(b)(6) 2019: symptomatic uti with hematuria (+) e.Coli.On (b)(6) 2019: new patient visit ¿ symptomatic chronic cystitis, pelvic/perineal pain, recurrent sui x 1 year, wears pull ups.On (b)(6) 2019: in-office cystoscopy ¿ unable to visualize urethra or place cystoscopy without reducing cystocele, mild bladder trabeculation urodynamics ¿ normal.Recurrent grade 3 cystocele, sui, chronic cystitis.On (b)(6) 2019: new patient visit ¿ claimant states she wants to be ¿fixed¿ grade 3 cystocele with palpable submucosal mesh, grade 2 uterine prolapse, sui.On (b)(6) 2019: abnormal urine odor, continued pelvic pain.On (b)(6) 2019: symptomatic uti with hematuria (+) e.Coli (+) mixed urogenital flora, sui due to pop, requesting second opinion.On (b)(6) 2019: worsening intermittent right sided flank pain, hematuria.On (b)(6) 2020: new patient visit ¿ claimant states sui and recurrent utis are severely affecting quality of life hematuria, chronic cystitis.On (b)(6) 2020: uti (+) klebsiella aerogenes (+) enterobacter aerogenes (+) mixed urogenital flora.On (b)(6) 2020: hematuria.On (b)(6) 2020: symptomatic uti (+) coagulase negative staphylococcus (+) lactobacillus species (+) gram negative rods (+) mixed flora ¿ no prominent organisms, no sensitivities will follow, a new specimen may be indicated.On (b)(6) 2020: new patient visit ¿ vaginal pain since (b)(6) 2010 surgery which claimant attributes to ¿mesh complication,¿ states first started having urinary problems ~2017.Bilateral urethral cording of the tot sling (monarch) at inferior/proximal side of pubic rami, mild pain (l >r) with palpation of this guitar string type tension.Vaginal pain at sling (monarch), groin pain, lateral cystocele, complete uterovaginal prolapse, rectocele, pelvic/perineal pain with bilateral nerve injury at hip/thigh level, sui.Plan: tot sling (monarch) sling removal from groin bilaterally with vaginal revision, hysteropexy, paravaginal repair with burch urethropexy, posterior repair, bilateral salpingo-oophorectomy.On (b)(6) 2020: discussed 3rd line therapy options: botox, interstim, ptns, she will follow up when ready to further discuss 3rd line options.On (b)(6) 2020: uti with hematuria.

Manufacturer Narrative

Correction: item number, udi number.Lot number: 100212-01.The lot number was reviewed for complaint trend, nonconforming report and capa.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.It is unknown if this device remains implanted or not.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.

• Brand Name: RESTORELLE M
• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13424122
• MDR Text Key: 284882366
• Report Number: 2125050-2022-00092
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K132061
• 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: 11/16/2022

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: 5013601400
• Device Catalogue Number: 501320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/16/2022
• 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): Other
• Patient Sex: Female