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

Model Number	5193002400
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.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, replaced left 1 cm rear tip extender with 1.5 cm rear tip extender.

• Brand Name: TITAN RTE KIT NARROW
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; 3050 ; DA 3050
• MDR Report Key: 8601399
• Report Number: 2125050-2019-00380
• Device Sequence Number: 16692634
• Product Code: FHW
• UDI-Device Identifier: 05708932527354
• UDI-Public: 05708932527354
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

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: 5193002400
• Device Catalogue Number: 519300
• Device Lot Number: 6000564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/10/2019
• 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: 36 YR