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
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.
Event or Problem Description
According to the available information, no malfunction noted.Correction of sizing.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the investigation.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device become available, or additional information is received, the complaint will be re-evaluated according to procedures.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

• 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: 8601392
• Report Number: 2125050-2019-00379
• Device Sequence Number: 2339204
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: 42 YR