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

Model Number	800018-14
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Damaged by Another Device (2915); Migration (4003); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note that the patient was the initial reporter.This submission initially failed when the patient/consumer option was selected for this form.Although uromedica had previously received preliminary information about this patient's experiences with proact, uromedica received the reportable information on 13 january 2021.Manufacturer's analysis: note that investigators were not able to confirm the cause of the infection via physical analysis.The following information is of unknown relatedness to the infection.Investigators identified a tear in the explanted proact balloon.The tear in the balloon originates from an area of circumferential wear located mid-length of the balloon.Uromedica has attempted to but cannot yet definitively identify the cause of the wear.The wear pattern is consistent with damage from contact with other components of the proact device or another object in the tissue (hemostasis clip or suture).The investigation is ongoing.Uromedica will submit any additional relevant findings in follow-up reports.Reference uromedica (b)(4).
Event or Problem Description
Infection in a proact patient.Infection was treated with antibiotics and resolved.

• Brand Name: PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
• Common Device Name: PROACT
• Manufacturer (Section D): UROMEDICA, INC.; 1840 berkshire lane north; plymouth MN 55441
• MDR Report Key: 11324142
• Report Number: 3003477176-2021-00001
• Device Sequence Number: 4125586
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 00180668000380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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 Model Number: 800018-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 102