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

Model Number 5192501400

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Erosion (1750); No Code Available (3191)

Event Date 03/22/2018

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.Should additional facts prompt us to alter or supplement any information of 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, pending erosion.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation.Requests for the explanted prosthesis and for additional information surrounding this event have been made.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.Review of nonconformances revealed no nonconformance with this lot that would have contributed to the event.Based on this knowledge, quality concludes that the erosion originated from source(s) other than the device.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.

• Brand Name: GENESIS KIT 9.5 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: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 7428381
• MDR Text Key: 105380625
• Report Number: 2125050-2018-00297
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

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: 5192501400
• Device Lot Number: 4939714
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 06/04/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR