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

Model Number 5192601400

Device Problems Fracture (1260); Malposition of Device (2616); Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Title: surgical outcomes at a single institution of infrapubic insertion of malleable penile prosthesis in transmen.Sun, 2023.Method: between october 2017 and may 2022, 40 transmasculine patients underwent mpp placement using either spectra (boston scientific device) or genesis (coloplast device).Initially, all patients underwent spectra mpp placement due to a favorable tip that was round and matched the glans contour well.However, due to the mostly metal composition of the prosthesis core with a thin silicone sheath, there was shearing of the silicone envelope when anchoring sutures were placed, resulting in frequent anchor site detachments.After october 15, 2019, all patients underwent placement of a genesis mpp, which was mostly silicone in composition with a thinner metal core.Complications were reviewed and categorized.Fisher¿s exact test with a p-value <.05 was used to assess significance between spectra and genesis mpp complications.This study was determined to be exempt from review by our institutional review board due to the use of de-identified data.Results: aes by product, for boston spectra and for coloplast genesis mpp: surgical revision (3 genesis); detachment (2 genesis); malposition (2 genesis); pain/activity limitation (0 genesis); infection (0 genesis).Conclusion: penile prosthesis placement after phalloplasty utilizing commercially available mpps is safe with the infrapubic technique.Surgical revision rates remain high and are comparable to other post-phalloplasty implant studies.The most common complications were malposition and detachment which were more common with the mostly metal mpp.Enhancements in technique and device design may help decrease the surgical revision rates associated with penile implant insertion after phalloplasty.

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.Publication citation sun hh, isali i, mishra k, callegari m, sellke nc, tay ks, gupta s, chen ml.Surgical outcomes at a single institution of infrapubic insertion of malleable penile prosthesis in transmen.Urology.2023 jan 18:s0090-4295(23)00035-3.Doi: 10.1016/j.Urology.2023.01.001.Epub ahead of print.Pmid: 36669571.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16553846
• MDR Text Key: 311406255
• Report Number: 2125050-2023-00285
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932324748
• UDI-Public: 05708932324748
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5192601400
• Device Catalogue Number: 519260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/16/2023
• 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: 42 YR
• Patient Sex: Transgender