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

Device Problem Migration (4003)

Patient Problems Edema (1820); Hematoma (1884); Pain (1994); Deformity/ Disfigurement (2360)

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.[(b)(4)].

Event Description

The following information was obtained from a literature article titled "post malleable penile prosthesis satisfaction in elderly patients: serial assessments" (doi: 10.1111/and.13399) dates noted in the article were: received 27 march 2019.Revised 17 july 2019.Accepted 24 july 2019.Copyright 2019 the study reviewed medical records from between may 2012 and august 2016.Three groups were implanted with genesis malleable: group 1: less than age 45 (32 patients, mean age 43.7) group 2: age 45-65 (35 patients, mean age 56) group 3: older than 65 years (30 patients, mean age 66.7).The article reported that in the post-operative period: six patients in group 1, five patients in group 2, and five patients in group 3 developed post-operative penile pain.Pain was noticed within the first week after surgery, and no patient exceeded level three of pain.Pain was controlled by nsaids.Post-operative penile oedema was limited to penile skin, with two patients in group 1, three patients in group 2 and three patients in group 3 experiencing this.Penile oedema was noticed on the first post-operative day and was secondary to surgical manipulation.Penile oedema resolved spontaneously in all patients.Cross-over (managed intra-operatively) occurred with one patient from group 1, and one patient from group 2.Penile bending was reported in one patient, from group 2.Haematoma was also reported as a recorded complication, but it was not specified how many patients or in what group(s) this occurred.

• 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: 9996483
• MDR Text Key: 189700503
• Report Number: 2125050-2020-00349
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• 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): Other; Required Intervention