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

Model Number 5013302400

Device Problems Degraded (1153); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Exposure to Body Fluids (1745); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Urinary Tract Infection (2120); Burning Sensation (2146); Injury (2348); Deformity/ Disfigurement (2360); Tissue Breakdown (2681); Nervous System Injury (2689); No Information (3190); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot number 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

As reported to coloplast though not verified, the legal representative stated revision surgery on (b)(6) 2019 as restorelle that was placed posteriorly had eroded into the vagina an additional 1.5 cm.In doctor's office cut the eroded mesh out.On (b)(6) 2019 revision surgery due to erosion of restorelle over a 2 cm portion.Excised the eroded mesh, debrided the edges of the excised posterior vagina and closed the vagina over the excision.The patient also had an altis revised on (b)(6) 2019 - noted in 21250050-2020-00430.Experienced degradation of the polypropylene mesh and the pelvic tissue, chronic inflammation of the pelvic tissue, mesh shrinkage or mesh contraction of the mesh causing chronic pain, mesh deformation causing chronic pain, nerve entrapment, chronic inflammation, chronic infectious response, significant urinary dysfunction, vaginal shortening, vaginal and rectal anatomic deformation, and sever adverse reactions to the mesh.Suffered and will suffer apprehension of increased risk for injuries, infections, bodily disfigurement.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Should additional information 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 information received reported that between (b)(6) 2018 and (b)(6) 2020, the patient experienced urinary leakage, sling tightened with tensioning suture, overactive bladder, midline posterior mesh and midline urethral mesh exposure, superficial separation of posterior incision line, mesh trimmed at posterior line on (b)(6) 2019, pain with sitting for extended periods of time, vaginal swelling and pressure, trimming of mid-urethral sling exposure in office (b)(6) 2019, vulvar itching, dysuria, pain and irritation after sex, numbing pain from the lower bottom area to the clitoris, dysuria, stress urinary incontinence, erythema of labia majora, mesh trimmed in office (b)(6) 2019, husband feels poling during intercourse, mesh exposure at left sulcus removed in office (b)(6) 2019, heavy incontinence with coughing and sneezing, sling exposure in the left sulcus, urinary hesitancy with weak stream, urge incontinence, popular lesion at right labia, bladder spams, small hole in vulva, vulvar fistula vs nerve bundle, right buttock pain, constipation, incomplete rectal emptying, and microscopic hematuria.On (b)(6) 2019 a 2 cm posterior mesh exposure from restorelle xl.On (b)(6) 2019 sling exposure in the left sulcus, stress urinary incontinence (sui) with suspected intrinsic sphincter deficiency of the urethra.It was further reported that the patient also experienced pelvic and vaginal pain that began after bladder sling repair and mesh removal surgery, urinary tract infection positive for escherichia coli, scar tissue, recurrent stage two vaginal vault prolapse, foreign body type inflammatory reaction, hemorrhoids, and hypertonic left levator ani muscles.The patient underwent pudendal nerve block, botox injection, and partial mesh excision.Additionally, urethral stinging, pinching, burning, and spasming, as well as disrupted stream when urinating.

• Brand Name: RESTORELLE XL
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10173144
• MDR Text Key: 201009641
• Report Number: 2125050-2020-00431
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: 5013302400
• Device Catalogue Number: 501330
• Device Lot Number: 6174725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Female