MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL RESIST 16CM; INFLATABLE PENILE PROSTHESIS

Model Number QS89161000

Device Problem Inflation Problem (1310)

Patient Problem No Information (3190)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

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 device was implanted over 10 years ago stopped working.It pumped but was not inflating.The 16cm titan with 2cm plus 3cm bilateral rte were removed.Another inflatable device was implanted.

Manufacturer Narrative

This follow-up mdr is created to document the return of the device and conclusion of the investigation.Device was received, and the condition of the device received indicated that the device was received to the pathology department in formalin.According to instruction, devices are not to be stored in formalin or other aldehyde-containing antiseptics, disinfectants or antimicrobials.Devices received in prohibited substances will not be evaluated by coloplast due to safety concerns.Therefore, this device receipt has been logged as received, but the device has been discarded and testing will not be performed.

• Brand Name: TITAN SCROTAL RESIST 16CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9655619
• MDR Text Key: 177237848
• Report Number: 2125050-2020-00115
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QS89161000
• Device Catalogue Number: QS8916
• Device Lot Number: 1000061-015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR