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

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

Patient Problems Hematoma (1884); Pocket Erosion (2013); Numbness (2415)

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 surgical technique for complex cases of peyronie's disease with implantation of penile prosthesis, multiple corporeal incisions, and grafting with collagen fleece" dates noted in the article were: received august 25, 2018.Accepted november 30, 2018.Copyright 2019, 16 patients were implanted with a genesis malleable device.27 patients were implanted with an ipp (either a non-coloplast ipp or a titan touch device, which is reported under 2125050-2020-00347).The patients were implanted between february 2015 and may 2018.The average patient age for the genesis malleable implants was 54.1.Per the article, the following complications were reported for the genesis malleable: 1 delayed distal corporeal erosion was recorded in a patient with a malleable device.For this case, the cylinder was explanted and the patient did well with a single cylinder.4 hematomas were recorded.All hematomas (or bruising) resolved.1 patient had glans numbness at 6 months.In addition, the below complications were reported, but it was not reported which device the complications occurred with: 12 patients had glans hypoesthesia at the 6-week revision.Only one of these patients continued to have symptoms at 6 months.

• 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: 9997963
• MDR Text Key: 191817583
• Report Number: 2125050-2020-00348
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2020

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: 03/27/2020
• Initial Date FDA Received: 04/24/2020
• 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; Other; Required Intervention
• Patient Age: 54 YR