MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89202400

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review.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 the available information the patient complained of distal pain, and curve to penis due to oversized implant.Another inflatable penile prosthesis was implanted, but the "resvervoir" remained.

Manufacturer Narrative

This follow-up was created to document the device return.Device was received, and the condition of the device received indicated that the device was received to the pathology department in formalin.According to instructions, 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.As examination of the device may not conclusively confirm or disprove the report of incorrect sizing quality accepts the physician's observations as to 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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

• Brand Name: TITAN SCROTAL ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9604345
• MDR Text Key: 183711874
• Report Number: 2125050-2020-00064
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487368
• UDI-Public: 05708932487368
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89202400
• Device Catalogue Number: ES8920
• Device Lot Number: 6293556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR