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

Model Number 5014402400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Pain (1994); Skin Erosion (2075); Urinary Retention (2119); Urinary Tract Infection (2120); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 11/07/2017

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced the following symptoms and procedures on the according dates: (b)(6) 2017: stage-ii anterior vaginal wall prolapse, stage-i vaginal vault prolapse after hysterectomy, stage-ii posterior vaginal wall prolapse, pubocervical and rectovaginal fascial weakness, incomplete bladder emptying, weak urinary stream, significant redundancy of the colon.Robotic-assisted laparoscopic sacrocolpopexy, laparoscopic-assisted abdominal cystocele repair, posterior repair, robotic-assisted left salpingectomy, cystourethroscopy to evaluate voiding dysfunction, enterocele repair under general anesthesia.(b)(6) 2019: stage i vaginal vault prolapse, pelvic pressure, pelvic floor weakness, bacterial vaginosis, incomplete bladder emptying, uti, urge incontinence, dyspareunia, atrophic vaginitis.(b)(6) 2019: dyspareunia, vaginismus, mesh erosion, urethral caruncle.(b)(6) 2019: dyspareunia, mesh erosion, chronic vaginal infections.(b)(6) 2019: mechanical malfunction of gu device, mesh erosion, dyspareunia.Laparoscopic mesh excision and cystoscopy under general anesthesia.(b)(6) 2019: urinary retention.(b)(6) 2019: mild post-operative surgical pain.(b)(6) 2019: dyspareunia.(b)(6) 2021: chronic pelvic pain.Pudendal nerve root block.(b)(6) 2021: chronic pelvic pain.Pudendal nerve root block.

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 (5666907) was reviewed for complaint trend, nonconforming report and capa.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14627550
• MDR Text Key: 294838798
• Report Number: 2125050-2022-00593
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 05708932483964
• UDI-Public: 05708932483964
• Combination Product (y/n): N
• PMA/PMN Number: K122440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2022

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 Model Number: 5014402400
• Device Catalogue Number: 501440
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/07/2022
• 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
• Patient Age: 52 YR
• Patient Sex: Female