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

Model Number	5192501400
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Erosion (1750); Fever (1858); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Myocardial Infarction (1969); Necrosis (1971); Pain (1994); Rash (2033); Skin Erosion (2075); Urinary Retention (2119); Localized Skin Lesion (4542)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to available information, an abstract titled, "which patient may benefit the most from penile prosthesis implantation?" was published in 2022.Study results do not appear to be broken down by product name, and since this study was funded by a grant from coloplast and from another device manufacturer, it seems that products from both companies are represented in this study population.Post operative complications for the study population, who were implanted between december 2014 and november 2017, included pain (1.1%), wound infection (1.8%), penoscrotal hematoma (3.4%), fever (0.7%), myocardial infarction (0.4%), local allergic rush (0.4%), urinary retention (0.4%), displacement of the reservoir (0.8%), cylinder extrusion (0.4%), scrotal extrusion (0.8%), urethral lesion (0.4%), and glans necrosis (0.4%).The study concluded that penile prosthesis implantation is associated with an overall good quality of life.The subset of patients affected by erectile dysfunction secondary to peyronie¿s disease seemed to benefit the most from penile prosthesis implantation in terms of functional outcomes, relationship with their partners and the outside world, and perceived self-image.
Additional Manufacturer Narrative
Citation: la croce g, schifano n, pescatori e, caraceni e, colombo f, bettocchi c, carrino m, vitarelli a, pozza d, fiordelise s, varvello f, paradiso m, silvani m, mondaini n, natali a, falcone m, ceruti c, salonia a, antonini g, cai t, palmieri a, dehò f, capogrosso p.Which patient may benefit the most from penile prosthesis implantation? andrology.2022 sep 11.Doi: 10.1111/andr.13294.Epub ahead of print.Pmid: 36088578.A2: mean age was 60 years (interquartile range: 56¿67).B3: reflects the date of the article.Patients were treated between 2014-2017.H6 codes: updated to include e0402, f12, d15.E1718 skin erosion has been removed and replaced with e2006 erosion.E061202 myocardial infarction has been removed.

• Brand Name: GENESIS MALLEABLE
• Common Device Name: 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: 15764421
• Report Number: 2125050-2022-01227
• Device Sequence Number: 18198057
• Product Code: FAE
• UDI-Device Identifier: 05708932324687
• UDI-Public: 05708932324687
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K040959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 5192501400
• Device Catalogue Number: 519250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male