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

Catalog Number 51956

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

According to the available information the following was reported: prior to surgery on 03/16/2017 the patient was experiencing urinary stream slower than before surgery, urine culture positive for e.Coli infection.On (b)(6) 2020 ct urogram showed dystrophic calcification inside the bladder, 1.5 cm, and bilateral simple renal cysts.On (b)(6) 2020 the patient experienced recurrent uti, and mesh erosion into bladder was observed.On (b)(6) 2020 surgery was performed for partial removal of the eroded supris mesh, with transvesical and cystoscopic lithotripsy, on (b)(6) 2023 mesh erosion into the bladder was observed with a new onset of nocturia 2x/night, urgency, and a recurrent uti.On (b)(6) 2023 a robotic procedure was performed for partial excision of the supris mesh and bladder closure.

Manufacturer Narrative

The lot number was reviewed for complaint trend, non-conforming report and capa.No trends were noted for complaints and there were no non-conforming reports or capas that were confirmed to be associated.

• 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: 18383076
• MDR Text Key: 331206331
• Report Number: 2125050-2023-01635
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 51956
• Device Lot Number: 4172236_5195622400
• Date Device Manufactured: 07/02/2014
• 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: 73 YR