MAUDE Adverse Event Report: COLOPLAST A/S TITAN; INFLATABLE PENILE PROSTHESIS

Model Number	ESR8162400
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Event or Problem Description
According to available information the physician explanted and replaced the device - reason unknown.No other adverse patient effects were reported.

• Brand Name: TITAN
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12295205
• Report Number: 2125050-2021-01119
• Device Sequence Number: 20014872
• Product Code: FHW
• UDI-Device Identifier: 05708932487528
• UDI-Public: 05708932487528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESR8162400
• Device Catalogue Number: ESR816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/09/2021
• Patient Sequence Number: 1
• Patient Age: 75 YR