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

Model Number 5013202400

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Muscle Weakness (1967); Dyspareunia (4505); Genital Bleeding (4507)

Event Type  Injury  

Event Description

According to available information, this device required revision due to exposure.The device was implanted during a robotic total laparoscopic hysterectomy, sacrocolpopexy for large uterine fibroids and stage 2 pelvic organ prolapse.This patient had a large fibroid uterus, which was removed through the vaginal cuff.The cuff was dilated significantly in order to accommodate removal.Because there were additional sutures that were required to close the cuff, the doctor thought this caused granulation tissue to grow.Post-op the patient began complaining of vaginal spotting and pain with intercourse.Granulation tissue was removed on (b)(6) 2021 this caused a weakening of the cuff whereby the device began to erode through.Patient had another procedure on (b)(6) 2022 where device erosion was detected and the cuff was revised.On (b)(6) 2022 another device exposure was diagnosed.Patient instructed to use vaginal estrogen cream daily for 1 month.Patient had a clinic visit on (b)(6) 2022 and the cuff defect had spontaneously healed.Patient was no longer complaining of vaginal bleeding and pain with intercourse on (b)(6) 2022.

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.

• Brand Name: RESTORELLE L
• 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: 15528135
• MDR Text Key: 301013401
• Report Number: 2125050-2022-01021
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5013202400
• Device Catalogue Number: 501320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• 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): Required Intervention