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

Catalog Number 91-9509SC / 519250

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

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.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 Description

According to available information, this device required replacement due to a wire break.No other adverse patient effects were reported.

Manufacturer Narrative

Examination of the device revealed that rod 1 was unable to maintain the retention angle.The rod was bent in four directions into approximately 45-degree angle but did not hold angle.With use over time, the coil inside the device may fatigue which could result in the loss of angle retention.Based on the testing, it was confirmed that the inner core of rod 1 most likely fractured.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 for this lot.

Event Description

According to the available information this genesis malleable revised due malfunction (wire breakage).

• Brand Name: GENESIS MALLEABLE PENILE PROSTHESIS
• Type of Device: PENILE PROSTHESIS, ROD/CYLINDER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17446437
• MDR Text Key: 320277984
• Report Number: 2125050-2023-00913
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932710831
• UDI-Public: 5708932710831
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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 Catalogue Number: 91-9509SC / 519250
• Device Lot Number: 8493967_5192502022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2023
• Date Device Manufactured: 04/22/2022
• 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): Required Intervention
• Patient Age: 61 YR