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

Model Number 5013202400

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Muscle Weakness (1967); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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

According to available information, this device required medication due to exposure.The device was implanted on (b)(6) 2022 during laparoscopic supracervical hysterectomy, sacrocervicopexy for stage 3 pelvic organ prolapse.Device exposure was detected on physical exam on (b)(6) 2022.This was an incidental finding and the patient was otherwise asymptomatic.The patient was prescribed vaginal estrogen but actually did not use it because her insurance didn't cover it.On (b)(6) 2022 the device exposure had spontaneously resolved.The patient was given a tube of estrogen from the clinic and instructed to use it regularly to prevent vaginal atrophy.The cause of the device exposure was deemed to be associated with vaginal atrophy.

• 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: 15527944
• MDR Text Key: 301011685
• Report Number: 2125050-2022-01020
• 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