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

Catalog Number	51956
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750); Fever (1858); Fistula (1862); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Deformity/ Disfigurement (2360); Hematuria (2558); Dyspareunia (4505); Genital Bleeding (4507); Cramp(s) /Muscle Spasm(s) (4521); Drug Resistant Bacterial Infection (4553); Urinary Incontinence (4572); Interstitial Cystitis (4862); Pelvic Pain (4865)
Date of Event	02/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.
Event or Problem Description
As reported to coloplast, though not verified: the patient had a supris retropubic sling implanted in (b)(6) 2014.From 2019, the patient reportedly had incontinence (urge and mixed), hematuria and an overactive bladder.From 2022 the patient reportedly had: vaginal mesh erosion, mesh excision, urethrolysis, urethral reconstruction and cystoscopy under anesthesia.Urethral erosion, urinary incontinence without sensory awareness, infected synthetic mesh, urethral vaginal fistula, anterior vaginal wall scarring, denervated urethral reconstruction, cadaver sling-fascia sling suspend/coloplast, left martius fat pad transposition, and use of gentrix surgical matrix/acell via general anesthesia.Stress urinary incontinence, intrinsic sphincter deficiency, low pelvic pain, bladder spasms, burning, irritation, uti-like symptoms.Cystoscopy and bulkamid injection via local anesthesia were given.Transvaginal urethrolysis was performed, category fascia lata suburethral sling, anterior repair with vaginal paravaginal repair and skin tissue rearrangement vaginal advancement of approximately 2 cm.From 2023, the patient reportedly had incision drainage and further cystourethroscopy, bladder botox injection and bulkamid injection via iv sedation.A raised area in pubic area was noted and a culture grew mrsa.Drainage was performed from the suprapubic wound with lump in pubic area.There was dehiscence of incision.Urinary incontinence persisted, pain and fevers.
Event or Problem Description
Additional information reported to coloplast, though not verified: the patient with this device experienced cystitis and abnormal vaginal discharge.The previously reported incision drainage, wound dehiscence and infection were not related to this device.
Additional Manufacturer Narrative
H10: this report is a duplicate of a previously filed report.This complaint was investigated to the extent information was provided to coloplast.Due to the nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

• Brand Name: SUPRIS RETROPUBIC KIT
• Common Device Name: 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: 20270598
• Report Number: 2125050-2024-01488
• Device Sequence Number: 17020474
• Product Code: OTN
• UDI-Device Identifier: 05708932490016
• UDI-Public: 05708932490016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 51956
• Device Lot Number: 3904711_5195622400
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female