MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS

Model Number	ES89142400
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
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.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, a leak was reported.
Additional Manufacturer Narrative
This follow-up mdr is created to document the additional event information.
Event or Problem Description
Additoinal information indicated the device was implanted in 2006.

• Brand Name: TITAN SCROTAL ZERO ANG 14CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; 3050 ; DA 3050
• MDR Report Key: 8593103
• Report Number: 2125050-2019-00362
• Device Sequence Number: 2293423
• Product Code: FHW
• UDI-Device Identifier: 05708932487306
• UDI-Public: 05708932487306
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: Lay User/Patient
• Device Model Number: ES89142400
• Device Catalogue Number: ES8914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/21/2019
• 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: Other
• Patient Age: 64 YR