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

Model Number 5192601022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Edema (1820)

Event Date 08/21/2017

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, patient submitted to penile prosthesis implantation on (b)(6) 2017 and evolved postoperatively with penile edema and purulent discharge from the surgical scar.

Manufacturer Narrative

Two genesis malleable rods were received for evaluation.Because quality's examination of the returned components may not conclusively confirm or disprove the report of infection, quality did not perform a microscopic examination.Based on the information provided quality accepts the physician's observations of such as the reason for surgical intervention.The review of the device lot history records by quality assurance indicates this lot passed sterility testing prior to being released.Based on this knowledge, quality concludes that the device was sterile prior to the device packaging being opened and that the infection originated from source(s) other than the device.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: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6974336
• MDR Text Key: 90124500
• Report Number: 2125050-2017-00526
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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: 5192601022
• Device Catalogue Number: 5192601022
• Device Lot Number: 5019201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 10/24/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 02/05/2018
• 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: 64 YR