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

Model Number 5192601400

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/07/2017

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

Malfunction.

Manufacturer Narrative

Two genesis malleable rods were received for evaluation.Examination and testing of the returned components revealed no functional abnormalities with both rods.Because the available information did not indicate what factors may have contributed to the reported "malfunction", and because no functional abnormalities were noted, quality cannot determine the cause of this reported event.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 11 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: 6702894
• MDR Text Key: 79667541
• Report Number: 2125050-2017-00092
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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: 5192601400
• Device Catalogue Number: 5192601400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 06/15/2017
• Supplement Dates FDA Received: 05/03/2018
• 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): Life Threatening; Other
• Patient Age: 69 YR