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

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 04/02/2019

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.

Event Description

The following information was obtained from a literature article titled "novel application of a irrigant wound vacuum system for management of infected penile prostheses in high risk patients" a patient developed a wound infection two weeks following placement of a coloplast genesis¿ malleable penile prosthesis and 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.Patient had no further complication to date.

• Brand Name: GENESIS
• 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 rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8951210
• MDR Text Key: 156892603
• Report Number: 2125050-2019-00704
• 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: literature
• Type of Report: Initial
• Report Date: 08/29/2019

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
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/30/2019
• 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): Other