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

Model Number	5192501400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Portions of this event were previously submitted via alternative summary report (exception number e1997039) submitted on 1/20/2014, this report is intended to be a follow up report to submit additional information that has been received.The information received indicated the device had a unspecified malfunction, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends or this lot.
Event or Problem Description
As reported to coloplast the patient have replacement and revision surgery due to an unspecified malfunction of the device.

• 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: 16942220
• Report Number: 2125050-2023-00585
• Device Sequence Number: 11588488
• Product Code: FAE
• UDI-Device Identifier: 05708932324687
• UDI-Public: 05708932324687
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: 5192501400
• Device Catalogue Number: 519250
• Device Lot Number: 3557267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2013
• 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: Other
• Patient Age: 41 YR
• Patient Sex: Male