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

Model Number	800018-14
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The scrotal port erosion was identified when the physician attempted to perform the patient's first adjustments resulting in a delay to therapy to achieve optimum continence with the proact implants.The physician plans to clean and/or rinse the port, adjust the device volume, place the port back in the patient's scrotum, and close the eroded skin with a suture in the or.A uromedica representative advised dr.Blick that device explantation is standard procedure for proact device erosions, however the physician elected to proceed with his plan.(b)(4).
Event or Problem Description
Scrotal port erosion through the skin (side unspecified) in a proact patient.

• 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: 12529797
• Report Number: 3003477176-2021-00014
• Device Sequence Number: 5173985
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 0100180668000380
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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
• Device Lot Number: UM00748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/24/2021
• 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