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

Model Number 5015202400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Emotional Changes (1831); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Discomfort (2330); Deformity/ Disfigurement (2360); Constipation (3274); Dyspareunia (4505); Genital Bleeding (4507); Sexual Dysfunction (4510); Urinary Incontinence (4572)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

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.The lot number (5485145) was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast received medwatch form mw5106994 for this complaint.

Event Description

According to available information, this device was explanted after the patient suffered vaginal pain, bladder pain, rectal pain, burning inflammation, and irritation.There were two revisions before the device was completely removed along with the patient's cervix which had been eroded through as well.The patient indicated she suffered significant harm physically, emotionally, and financially.

Event Description

Additional information received, though not verified, reported the patient also experienced inter alia, dyspareunia, urgency problems, erosion of the vaginal wall and other tissues, infection, incontinence, permanent physical deformity, the loss of ability to perform sexually, permanently diminished enjoyment of life, and difficulty with daily activities.

Manufacturer Narrative

The patient had both restorelle y contour mesh and an aris sling implanted during the same procedure; see manufacturer report number 2125050-2022-00300 regarding the aris sling.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received on 02/05/2023 includes patient symptoms of vaginal bleeding, vulvar irritation and general vaginal discomfort.Urinary retention.Difficulty and incomplete eliminating of bowels.White vaginal discharge 6 weeks s/p vaginal mesh excision.Patient also reports straining with bowel movement with rectal discomfort and bulge.Mri of pelvis due to sensation of needing to defecate, rectal and vaginal pressure with burning.Transabdominal, transvaginal ultrasound performed.Intermittent vaginal yeast and bacterial infections treated with medication.

• Brand Name: RESTORELLE Y CONTOUR
• 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: 13767208
• MDR Text Key: 287191939
• Report Number: 2125050-2022-00247
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 05708932528108
• Combination Product (y/n): N
• PMA/PMN Number: K140116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Followup,Followup
• Report Date: 02/13/2023

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: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Model Number: 5015202400
• Device Catalogue Number: 501520
• Device Lot Number: 5485145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/18/2022; 02/05/2023
• Supplement Dates FDA Received: 03/24/2022; 02/13/2023
• Date Device Manufactured: 02/01/2017
• 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): Disability; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female