MAUDE Adverse Event Report: COLOPLAST A/S GENESIS KIT 9.5 COATED; PENILE PROSTHESIS

Model Number 5192501400

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Erosion (1750)

Event Date 11/06/2018

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, erosion/extrusion.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A portion of malleable rod was received for evaluation.Examination of the returned components revealed no abnormalities that would have contributed to the report of erosion/extrusion.However, because quality's examination of the returned components may not conclusively confirm or disprove the report of erosion/extrusion, quality accepts the physician's observations of such as the reason for surgical intervention.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.Requests for the device and for additional information surrounding this event have been made.However, to date neither the device nor the information has been received.Without the benefit of analyzing the device and without the requested information, quality cannot comment on the condition of the device or the events surrounding this incident.If the device or additional information is received, quality will re-evaluate this event in accordance with procedures.However, because quality's examination may not conclusively confirm or disprove the report of erosion/extrusion, quality accepts the physician's observations of such as the reason for surgical intervention.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 3659959.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

• Brand Name: GENESIS KIT 9.5 COATED
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8157097
• MDR Text Key: 130161805
• Report Number: 2125050-2018-00878
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932324687
• UDI-Public: 05708932324687
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2019

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: 5192501400
• Device Catalogue Number: 519250
• Device Lot Number: 3659959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 11/15/2018
• Supplement Dates FDA Received: 01/22/2019; 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR