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

Model Number 5192601400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 12/02/2019

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 malleable device was explanted and replaced with an inflatable prosthesis due to patient preference.There was no reported issue with the device.

• Brand Name: GENESIS KIT 11 COATED
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 9535765
• MDR Text Key: 173222416
• Report Number: 2125050-2019-01181
• 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
• Report Date: 12/26/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: 5192601400
• Device Catalogue Number: 519260
• Device Lot Number: 6607112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR