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

Model Number 5192601400

Device Problems Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and 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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the rods were unequal in size, which caused issues with usage/penetration.The device was removed and replaced.

Event Description

This follow-up mdr is created to document the additional event information received for record #622457.According to the available information the malleable penile prosthesis was implanted on (b)(6) 2019 and removed/replaced on (b)(6) 2020 due to usage issues.Additional information received from the territory manager indicated: ¿sized being unequal caused penetration issues.Device was fully intact.¿ further information received indicated: ¿implant not even¿.Two malleable rods were received for evaluation.As examination of the device may not conclusively confirm or disprove the report of use error 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.

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.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10836972
• MDR Text Key: 216153605
• Report Number: 2125050-2020-01093
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5192601400
• Device Catalogue Number: 519260
• Device Lot Number: 6398730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR