MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS RETROPUBIC SLING SYSTEM; SURGICAL MESH

Model Number 5195612400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Pain (1994)

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.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, llq abdominal pain, yeast infections x 3 since 11/2010, pelvic pain, extrusion /infection of supris/coloplast, periurethral fibrosis, recurrent utis, vaginal pain/ bleeding.On (b)(6) 2020: complete excision of supris/coloplast, urethrolysis, resection/closure of disrupted vaginal/suburethral mucosa, cystoscopy.Intraoperative findings: disruption of supris/coloplast incision with extrusion of supris/coloplast, purulent/malodorous material noted along the course of the sling extending bilaterally to supris/coloplast margins (cultured), suburethral fibrosis that required urethrolysis.No other adverse patient effects were reported.

• Brand Name: SUPRIS RETROPUBIC SLING SYSTEM
• 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: 12573663
• MDR Text Key: 274721273
• Report Number: 2125050-2021-01433
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 5195612400
• Device Catalogue Number: 519561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR