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

Model Number 5192602022

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Erosion (2075)

Event Date 11/30/2021

Event Type  Injury  

Event Description

According to available information, device required explantation due to erosion in one of the cylinders.No additional adverse patient effects were reported.

Manufacturer Narrative

The lot # 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.

Manufacturer Narrative

Corrections based on additional information received: d4 lot number & expiration date, h4 manufacturing date.

Manufacturer Narrative

One malleable rod was received for evaluation.Examination of the returned component revealed no abnormalities that would have contributed to the report of erosion.However, because examination of the returned component may not conclusively confirm or disprove the report of erosion, quality accepts the physician¿s observations of such as the reason for surgical intervention.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 the malleable penile prosthesis was implanted on (b)(6) 2021 and revised on (b)(6) 2021 due to erosion in one of the cylinders.

• Brand Name: GENESIS MALLEABLE
• Type of Device: 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: 13029207
• MDR Text Key: 282492657
• Report Number: 2125050-2021-01817
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 5192602022
• Device Catalogue Number: 519260
• Device Lot Number: 7855497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/11/2022; 01/20/2022
• Supplement Dates FDA Received: 01/17/2022; 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male