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

Catalog Number 91-9509SC / 519250

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Unspecified Infection (1930); Pain (1994); Sexual Dysfunction (4510)

Event Type  Injury  

Event Description

Method: anesthesia method is local anesthesia (penile block) (b)(4), general anesthesia 13 cases.Penile prostheses were ams 700cxm 6 cases, titan otr narrow base (coloplast) 2 case, hydroflex 1 case, ams dura ii (b)(4), ams 600 (b)(4), genesis (coloplast) (b)(4), koken (japan) (b)(4).We have used ams since 1992, the sale of penile protheses in japan was halted in 2007.Since 2008, our university doctors have been ordering coloplast prostheses implanted penile prosthesis size is 11-19.5cm length average 15.9cm, median 16cm.The diameter is dura ii 1cm (b)(4)), ams 600 0.95cm (b)(4) 1.15cm (b)(4)genesis 1.1cm (b)(4), genesis 0.95cm (b)(4)).Day surgeries are popular therefore (b)(4) of patients prefer a non-inflatable prosthesis.We devised a single-implant procedure and performed surgery for the following indications:1.Narrow cavernosum because of congenital abnomarity or re-operations.2.Small penis.3.Uncontrolled diabetes.4.Ed caused by corporal veno-occlusive dysfunction (cvod) in a young man.5.Patient preference for a warm erect penis (with a pde5 inhibitor).Single implant surgery has a high satisfaction rate of(b)(4) with no complications, but there are still many enlargement operations and use of pde5 inhibitors.Results: intercourse was possible (b)(4) and impossible (b)(4).Ejaculation was possible 100cases (b)(4).Impossible (b)(4).(prostate or rectal surgery, retrograde ejaculation due to dm).Complication rate is (b)(4), exposure of one side prosthesis to urethra (b)(4), exposure of one side prosthesis to skin (b)(4), exposure of tube (ams700cxm) (b)(4), persistent pain (b)(4) infection (b)(4).Satisfaction rate is (b)(4) conclusion: the penile prosthesis is still considered to be the surgical gold standard for treatment of ed.All other available treatments for ed should be compared with the results of penile prosthesis surgery.In japan, (b)(4) of day surgeries use non-inflatable prostheses.Disclosure: work supported by industry: no.

Manufacturer Narrative

Title: penile implants in japan.Author(s): nagao, k.; nakajima, k.Penile implants in japan.J sex med volume 19 s193.

• Brand Name: GENESIS MALLEABLE PENILE PROSTHESIS
• Type of Device: PENILE PROSTHESIS, ROD/CYLINDER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18607681
• MDR Text Key: 334142010
• Report Number: 2125050-2024-00163
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2024

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 Catalogue Number: 91-9509SC / 519250
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male