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

Model Number 5192602022

Device Problem Missing Information (4053)

Patient Problems Unspecified Infection (1930); Perforation (2001)

Event Date 09/30/2020

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, though not verified, genesis implant: infection and perforation in the proximal part.Pus was coming out of the urethra.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usrll rachel lloyd ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10786724
• MDR Text Key: 214608554
• Report Number: 2125050-2020-01039
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2020

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: Health Professional
• Device Model Number: 5192602022
• Device Catalogue Number: 519260
• Device Lot Number: 7254078
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1