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); Device Operational Issue (2914)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/01/2017

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, device malfunction.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.According to the available information this inflatable penile prosthesis was implanted on (b)(6) 2016 and removed/replaced on (b)(6) 2017 due to a malfunction.Requests have been made for additional information surrounding the incident.However, to date the requested information has not been received.Two genesis malleable rods were received for evaluation.Examination and testing of the returned components revealed a separation in the middle of rod #1 and rod #2.The separation appears to be rough and irregular, indicating sufficient stress was exerted.Because the limited information provided does not indicate any factors that may have contributed to the reported event, quality cannot determine or comment on the sequence of events resulting in the observed separations.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: stephanie perryman ; 1601 west rivier road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 7034282
• MDR Text Key: 92096474
• Report Number: 2125050-2017-00572
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

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: 4336607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 69 YR