MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS RETROPUBIC KIT; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 51956

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Erosion (1750); Micturition Urgency (1871); Scar Tissue (2060); Urinary Tract Infection (2120); Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced recurrent urinary tract infections, chronic cystitis, hematuria, stress urinary incontinence, renal/bladder stones as nidus of infection, urethral hypermobility, large urethral calculus is likely cause of recurrent urinary tract infections, device erosion, and some left parapelvic cysts.Patient had a computerized tomography scan of her abdomin and pelvis.The patient had a cystoscopy exploration and a laser removal of bladder / urethral stone.Intraoperative findings noted a large irregular bladder stone on right side of urethra encompassing urethra from the mid urethra at the bladder neck and a large amount of eroded device underlying area of stone formation within the urethra.The patient had a vaginal exploration, device explantaion that was difficult, urethral reconstruction on the right side, two cystoscopies and a catheter placement.Patient had a transvaginal exploration with explantation of the residual device, cystotomy repair, three cystoscopies, hemostatic matrix application, and a catheter placement.Pathology noted a squamous/dense fibrovascular tissue with mixed inflammation, foreign material, and a foreign-body giant cell reaction red stained, partially cauterized, mesh-like material partially surfaced by pink-red hemorrhagic tissue.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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

Additional information received on 12/2/2023, provides additional patient symptoms of urge incontinence.

• Brand Name: SUPRIS RETROPUBIC KIT
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17739394
• MDR Text Key: 323321099
• Report Number: 2125050-2023-01124
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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 Expiration Date: 09/30/2016
• Device Catalogue Number: 51956
• Device Lot Number: 3337030_5195622400
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2023
• Date Device Manufactured: 06/18/2012
• 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: 65 YR