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

Model Number 5195612400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Anemia (1706); Emotional Changes (1831); Fever (1858); Nausea (1970); Pain (1994); Sepsis (2067); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Vomiting (2144); Malaise (2359); Hematuria (2558); Intermenstrual Bleeding (2665); Dysuria (2684); Kidney Infection (4502); Dyspareunia (4505)

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 an emergency department visit for urinary retention with a bladder scan of 513 ml.Patient stated the post implant stitches were "driving her crazy", unable to void without a foley catheter, low back and sacral pain, dysuria, recurrent urinary tract infections with positive e.Coli, constant throbbing bladder pain except when urinating, intermittent self-catheterization, urinary urgency, urinary frequency, urethral dilation, cystoscopy, crying, feeling horrible, urinary tract infection positive for group b streptococcus agalactiae, bladder pressure, nocturia, urinary hesitancy, incomplete bladder emptying, slow stream, severe sepsis from infected left ureteral stone, diagnostic left ureteroscopy, and retrograde pyelogram.Patient had an emergency department visit for vaginal bleeding.Patient had a urinary tract infection with hematuria, vaginal discharge, perianal pain, a constant struggle to void that was very bothersome.Patient had a partial explantation of an unknown sling device and closure of vaginal wall defect.Intraoperative findings noted the sling device appeared to be curled up and more distal than expected and the vaginal wall defect under the urethra due to the device.Patient had an emergency department visit for severe sepsis with fever, altered mental status, and severe anemia due to a urinary tract infection with positive staphylococcus epidermidis and left hydronephrosis / nephrolithiasis.Patient had a cystoscopy and a left ureteral stent placement.Repeat cystoscopy, left ureteral stent removal, left ureteral stone basket extraction.Patient had a pelvic mri that noted likely transvaginal or suprapubic device with mild scarring of left arm of the device, likely posterior vaginal wall device, and no obvious mesh extrusion or evidence of inflammation.In-office cystoscopy noted diffuse cystitis cystica.A renal ultrasound noted bilateral pelviectasis.Patient had a bladder stimulator device implanted for hypotonic bladder.Patient had an emergency department visit to hospital admission for intolerable bladder symptoms including abdominal pain, nausea, vomiting, flank pain, vaginal pain, and still requires intermittent self-catheterization every day or two.She had an abdominal and pelvic ct that noted some thickening of bladder wall suggesting chronic cystitis, normal kidneys, current acute infection, symptoms likely due to chronically thickened hypotonic bladder that is irritable and prone to symptoms, very possible bladder stimulator may be contributing to painful symptoms and/or exacerbating bladder symptoms.Patient had an emergency department visit with emergency medical service transport for transfer to hospital admission for urinary tract infection with positive e.Coli, positive extended spectrum beta-lactamase (esbl) and urinary retention.Patient had an emergency department visit to hospital admission for recurrent urinary tract infection, acute on chronic urinary retention and still requires intermittent self-catheterization.

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.The lot number was reviewed for complaint trend, nonconforming report, and capa.No ncs nor capas were identified.Devices met specification prior to release.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16174245
• MDR Text Key: 307497224
• Report Number: 2125050-2022-01486
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 03/07/2023

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 Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 5195612400
• Device Catalogue Number: 519561
• Device Lot Number: 3079610
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/07/2023
• Date Device Manufactured: 12/02/2011
• 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; Hospitalization
• Patient Age: 50 YR