MAUDE Adverse Event Report: COLOPLAST A/S GENESIS MALLEABLE; PENILE PROSTHESIS

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

Patient Problems Purulent Discharge (1812); Post Operative Wound Infection (2446)

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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.One additional patient was reported in this article.This patient was reported under 2125050-2020-00382.

Event Description

The following information was obtained from a literature abstract titled "novel application of a irrigant wound vacuum system for management of infected penile prostheses in high risk patients" obtained from j sex med 2019.Per the article, a patient developed a wound infection two weeks following placement of a genesis malleable penile prosthesis and unknown testicular prosthesis.He was admitted for intravenous antibiotics and had bedside removal of testicular prosthesis and placement of a rectangular sponge in the scrotal incision after closure of corporal bodies.After five days the patient was discharged home with the device and seen twice weekly in the office for vacuum changes.He was hospitalized for two days, two weeks after discharge for purulent discharge from his wound and received 10 days meropenem via a jacc line.Six weeks after the initial surgery the wound vacuum was discontinued, and a dressing was applied for a total of one week, after which the wound had completely closed.The patient has had no further complications to date.

• Brand Name: GENESIS MALLEABLE
• 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
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10058390
• MDR Text Key: 193960015
• Report Number: 2125050-2020-00381
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/14/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention