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

Model Number 5192601400

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 11/08/2019

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

Event Description

According to the available information, the device was removed and replaced with an inflatable device, per patient choice.No malfunction.It was reported the patient wanted to achieve more girth.2cm were removed from rear tips of implants cylinders.

Manufacturer Narrative

The follow-up is created to document conclusion of the investigation and updated device infomation.Two malleable rods were received for evaluation.As examination of the device may not conclusively confirm or disprove the report of patient preference quality accepts the physician's observations as to the reason for surgical intervention.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• 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: 9433022
• MDR Text Key: 169802001
• Report Number: 2125050-2019-01103
• 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: 01/17/2020

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: 6336737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR