MAUDE Adverse Event Report: UROMEDICA, INC. PROACT ADJUSTIBLE CONTINENCE THERAPY FOR MEN

Device Problem Migration (4003)

Patient Problems Erosion (1750); Unspecified Infection (1930); Hematuria (2558); Dysuria (2684); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 12/30/2022

Event Type  Injury  

Manufacturer Narrative

The patient initially presented in the er but the interventions were completed by dr.(b)(6).Uromedica complaint (b)(4).

Event Description

The patient presented with urinary difficulty and hematuria.Visualization with cystoscopy confirmed a left-side balloon erosion at the bladder neck resulting in extraperitoneal urine leakage and infection with edema build up in a proact patient.The patient was catheterized to treat the erosion, however the proact device could not be explanted due to the edema build up.The infection was treated sucessfully with antibiotics and the patient was bi-laterally explanted at a later date.

Manufacturer Narrative

Updated information related to the return of the explanted proact devices and adverse event problem codes at the conclusion of the investigation.Uromedica (b)(4).

• Brand Name: PROACT ADJUSTIBLE CONTINENCE THERAPY FOR MEN
• Type of Device: PROACT
• Manufacturer (Section D): UROMEDICA, INC.; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer (Section G): UROMEDICA, INC.; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer Contact: lisa van ryn ; 1840 berkshire lane north; plymouth, MN 55441
• MDR Report Key: 16250633
• MDR Text Key: 308232878
• Report Number: 3003477176-2023-00004
• Device Sequence Number: 1
• Product Code: EZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Male