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

Model Number	ES88142400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Event or Problem Description
According to the available information, though not verified, fluid loss - no noticeable break.The device was removed/replaced.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• Brand Name: TITAN
• Common Device Name: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10958765
• Report Number: 2125050-2020-01198
• Device Sequence Number: 19645844
• Product Code: FHW
• UDI-Device Identifier: 05708932487160
• UDI-Public: 05708932487160
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: ES88142400
• Device Catalogue Number: ES8814
• Device Lot Number: 4326719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/07/2020
• Patient Sequence Number: 1
• Patient Age: 48 YR