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

Model Number	5192701400
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is a follow-up to mfr# 2125050-2020-00025.According to the available information a genesis malleable was implanted on (b)(6) 2017 and removed on (b)(6) 2019 due to a malfunction.
Additional Manufacturer Narrative
Genesis malleable rods 1 and 2 were received for evaluation.Rod 1 was received fully separated.The detachment ends of the separated pieces of the rod showed surfaces to be rough and irregular, indicating stress was exerted.The inner core for rod 1 was separated.Further examination by the sustaining engineer manager indicate there was limited blood on the inside of the malleable, which may indicate the breakage noted occurred after explant.Microscopic examination revealed that there appeared to be silver strands missing from the inner core and the coil aspect appears as if it was cut.The sustaining engineer manager also noted that there was a small area near the separation site where the outer overmold may have been reworked, which is an acceptable process during production.Based on examination and testing, and further examination by the sustaining engineering manager, it was confirmed that the inner core of the malleable rod 1 most likely fractured and as a result of the inner core fracture, the outer rod material may have started to fracture noted by the rough and irregular detachment surfaces.It was noted that a non-coloplast malleable was also returned with this file, but the non-coloplast rod was a different diameter.As the limited information received does not provide further details into the event, and based on examination of the returned product, it is unclear when the full separation of the malleable rod 1 may have occurred.The malleable device was replaced with a titan touch inflatable device.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12804703
• Report Number: 2125050-2021-01655
• Device Sequence Number: 11927601
• Product Code: FAE
• UDI-Device Identifier: 05708932324809
• UDI-Public: 05708932324809
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 10/17/2020
• Device Model Number: 5192701400
• Device Catalogue Number: 519270
• Device Lot Number: 4859646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2016
• 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: 65 YR
• Patient Sex: Male