MAUDE Adverse Event Report: COLOPLAST A/S GENESIS KIT 11 COATED; PENILE PROSTHESIS

Model Number 5192601400

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.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 genesis was explanted and replaced with an inflatable prosthesis due to patient preference.The device had been implanted to hold space for an inflatable prosthesis.

Manufacturer Narrative

Device was received, and the condition of the device received indicated that the device was received to the pathology department in formalin.According to instruction, devices are not to be stored in formalin or other aldehyde-containing antiseptics, disinfectants or antimicrobials.Devices received in prohibited substances will not be evaluated by coloplast due to safety concerns.Therefore, this device receipt has been logged as received, but the device has been discarded and testing will not be performed.

• Brand Name: GENESIS KIT 11 COATED
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9650450
• MDR Text Key: 177135393
• Report Number: 2125050-2020-00070
• 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
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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
• Device Model Number: 5192601400
• Device Catalogue Number: 519260
• Device Lot Number: 6563792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR