MAUDE Adverse Event Report: COLOPLAST A/S GENESIS KIT 9.5 COATED; PENILE PROSTHESIS

Model Number 5192501400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Post Operative Wound Infection (2446)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

Two malleable rods were received for evaluation.As examination of the device may not conclusively confirm or disprove the report of infection, quality accepts the physician's observations as to the reason for surgical intervention.The review of the device lot history records indicates this lot passed sterility testing prior to being released.The device was sterile prior to the device packaging being opened and that the infection originated from source(s) other than the 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.

Event Description

According to the available information, some time after implantation, a scrotal wound broke down, and the penis gradually became tender and infected.The decision was made to removed the device.The device was not replaced.The patient returned to the recovery room in stable condition.

• Brand Name: GENESIS KIT 9.5 COATED
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 9325318
• MDR Text Key: 166531649
• Report Number: 2125050-2019-01022
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932324687
• UDI-Public: 05708932324687
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 11/14/2019

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: 5192501400
• Device Catalogue Number: 519250
• Device Lot Number: 5531636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR