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

Model Number 5195612400

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Frequency (2275)

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.Once our evaluation is complete, 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, legal representative stated debilitating injuries, inter alia, severe pelvic pain, painful intercourse, infections, recurrence of incontinence, urinary problems and a revision surgery on (b)(6) 2017, suffered permanent injuries and will suffer apprehension of increased risk for injuries, infections, pain, discharge, and multiple corrective surgeries, operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue, an nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia, urinary incontinence physical deformity, and the loss of the ability to perform sexually, erosion of the vaginal wall and other tissues, infection.

• 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: usrll rachel lloyd ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10983290
• MDR Text Key: 220659960
• Report Number: 2125050-2020-01243
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2020

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: 11/11/2020
• Initial Date FDA Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1