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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/31/2019

Event Type  Injury  

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 Description

According to the available information, the malleable device was removed from right side, and an inflatable device was inserted on both sides.

Event Description

Additional information indicated the malleable device was implanted to hold space in the corpora.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information.The device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of placeholder quality accepts the physician's observations as to the reason for surgical intervention.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

• Brand Name: GENESIS
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9504446
• MDR Text Key: 172469442
• Report Number: 2125050-2019-01168
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR