MAUDE Adverse Event Report: NON-COLOPLAST TITAN TOUCH SCRO ZERO ANG 22CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29222400

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

A review of the review of the lot number for complaint trend, nonconforming report and capa review was completed.No trends 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 placement of the cylinder was outside the corpus body.No product defect was reported.Additional information stated "the cylinder was not placed correctly.It was not in the corpora.".

Manufacturer Narrative

This follow-up mdr is created to document the additional information that indicated the device is not a coloplast product.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): NON-COLOPLAST; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8962018
• MDR Text Key: 156560699
• Report Number: 2125050-2019-00717
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539203
• UDI-Public: 05708932539203
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29222400
• Device Catalogue Number: ES2922
• Device Lot Number: 6022127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR