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

Model Number 5192601400

Device Problem Fluid/Blood Leak (1250)

Patient Problem Unspecified Infection (1930)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, per territory manager: the malleable placed approximately three months ago has had drainage.The device was removed/replaced.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This follow-up mdr is created to document the additional event information received for record (b)(4).According to the available information the malleable penile prosthesis was implanted in (b)(6) 2020 and removed/replaced on (b)(6) 2020 due to infection.Additional information received from the territory manager indicated: ¿the malleable placed approximately three months ago has had drainage.¿ the device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of infection 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 MALLEABLE
• Type of Device: PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10590967
• MDR Text Key: 208722542
• Report Number: 2125050-2020-00886
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932324748
• UDI-Public: 05708932324748
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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: Health Professional
• Device Model Number: 5192601400
• Device Catalogue Number: 519260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/26/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 10/20/2020
• Patient Sequence Number: 1
• Patient Age: 58 YR