MAUDE Adverse Event Report: COLOPLAST CORP RESTORELLE M RECT 15X10CM; SURGICAL MESH

Model Number 5013202400

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Pocket Erosion (2013); Skin Irritation (2076); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Hematuria (2558); Dysuria (2684); No Information (3190); No Code Available (3191); Constipation (3274)

Event Date 01/17/2019

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 that some restorelle was excised based upon a suspicion of erosion of the mesh into the patient's vagina as her husband had complained of something sticking him during sexual relations.

Event Description

As reported to coloplast though not verified, additional information received stated patient experienced uti, microscopic hematuria, cystoscopy, dyspareunia, pelvic pain.Exam under general anesthesia.Cystoscopy showed bladder base induration, erythema, and purulent exudative process at the periphery.Serial urinalysis showed worsening pyuria and microscopic hematuria sometimes without positive cultures.No frank mesh erosion, but suspected that mesh may be migrating into bladder wall and causing these reactionary changes.

Manufacturer Narrative

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 new event information and corrected implant date.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received indicated the patient experienced infection, retention, pain, inflamation, hematuria.

Event Description

As reported to coloplast though not verified, post op notes, history of laparoscopic sacrocolpopexy, midurethral sling placement, cystoscopy on 6/15/2017 and laparoscopic mesh excision of anterior leaflet on (b)(6) 2019 for suspected mesh erosion (though no evidence of mesh exposure intraoperatively).

Manufacturer Narrative

This follow-up was created to document the additional information.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Manufacturer Narrative

This follow-up was created to document the additional information.Patient codes (b)(6)-urine in stool.(b)(6)- bowl issues.Device code 3190 due to exposure of mesh for unknown reasons.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, additional information received stated acute cystitis, dyspareunia with small lump in back of vagina tender to palpation, incomplete bladder emptying, acute cystitis, recurrent uti's, acute cystitis, positive urine culture enterococcus faecalis, positive urine culture, e.Faecalis, urine culture: escherichia coli, constipation, right flank pain, enterocele 2-3+, rectocele 1+, cystocele, rectocele, enterocele, urine culture: klebsiella pneumoniae, bladder prolapse, fistula, suprapubic pain, slow void, feels like still full after urination, urine frequency, urge and dysuria.Claimant notes she has to put finger high in vagina to help empty bladder, recurrent cystitis, found to have myofascial restrictions and levator ani tension.(b)(6) 2018 or (b)(6) 2018 - infections consistently for 1.5 years and also abdominal pain since the surgery.Recurrent rectal and vaginal prolapse leakage with lifting and coughing.Claimant states there is urine in her stool, microscopic hematuria.Exam under general anesthesia.Cystoscopy's showed bladder base induration, erythema, and purulent exudative process at the periphery.Serial urinalysis show worsening pyuria and microscopic hematuria sometimes without positive cultures.No frank mesh erosion but suspected that mesh may be migrating into bladder wall and causing these reactionary changes.Claimant mentioned that she and her husband had intercourse since her last visit and as a result he noticed that the act "cut him", impending mesh erosion.(b)(6) 2019 - presents for pre-op evaluation, for scheduled surgery, to evaluate for possible mesh exposure in vagina.Plan to proceed with laparoscopic mesh excision secondary to suspected impending mesh erosion into the bladder from her anterior sacrocolpopexy mesh.Urology will likely to place stents at beginning of case.(b)(6) 2019 - suspected erosion of implanted vaginal mesh and revision of mesh via laparoscopic approach under general anesthesia.There was an area where vaginal epithelium was so thin along left lateral wall that there was a small defect.3 sutures of 2.0 pds placed, interrupted, to close this defect and to imbricate vaginal tissue for more thickness.The mesh was not close to this suture repair.There were no signs that mesh was infected.It was noted to be well placed prior to removal.Low back pain, vaginal pain on left side, continued leakage with laugh/cough/sneeze, leakage with urgency, dysuria, feeling of incomplete bladder emptying, bowel issues, exposed mesh posteriority.(b)(6) 2020 - removal of abdominal mesh, lysis of bowel adhesions, uterolysis, upper colpectomy, abdominal enterocele repair, removal of retropubic sling, urethral lysis, anterior colporrhaphy, abdominal paravaginal repair under general anesthesia.

• Brand Name: RESTORELLE M RECT 15X10CM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis, MN 55411
• MDR Report Key: 8831237
• MDR Text Key: 152340884
• Report Number: 2125050-2019-00603
• 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: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/10/2020

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: Health Professional
• Device Model Number: 5013202400
• Device Catalogue Number: 501320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 06/27/2019; 06/27/2019; 06/27/2019; 06/27/2019
• Supplement Dates FDA Received: 02/03/2020; 04/03/2020; 06/02/2020; 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR