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

Model Number 5192701022

Device Problems Break (1069); Material Too Rigid or Stiff (1544)

Patient Problem Pain (1994)

Event Date 06/28/2020

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, a genesis was implanted in 2010.During last 6 months the patient cannot unbend and bend the implant.It keeps same curve position.During bending attempt he heard a crack and felt pain.A new genesis was implanted.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information this malleable penile prosthesis was implanted on (b)(6) 2010 and removed and replaced on (b)(6) 2017 due to a malfunction.Information received indicated that during an attempt to bend the device, the patient heard a crack and felt pain.During the last six months, the patient was not able to bend and unbend the implant.It kept the same curve position, and the rods do not expand.Each of the rods was bent in four directions into approximately a 45-degree angle.The rods did not hold the angle.With use over time the coil core inside the device may fatigue, which may result in the loss of angle retention as noted with this 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, non-conformances and capas revealed no trends for this lot.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10410873
• MDR Text Key: 203139537
• Report Number: 2125050-2020-00726
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

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 Model Number: 5192701022
• Device Catalogue Number: 519270
• Device Lot Number: 1697401R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 38 YR