MAUDE Adverse Event Report: COLOPLAST A/S TITAN ZERO ANG CYLINDER 24CM; INFLATABLE PENILE PROSTHESIS

Model Number E179242400

Device Problems Break (1069); Crack (1135)

Patient Problem No Information (3190)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete.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, cracked tubing.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation and correct that the device has not been returned for investigation.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device become available, or additional information is received, the complaint will be re-evaluated according to procedures.As no lot # was provided, a review of the device history record, complaint history database, nonconformance's and capas could not be completed.

• Brand Name: TITAN ZERO ANG CYLINDER 24CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; 3050 ; DA 3050
• MDR Report Key: 8634316
• MDR Text Key: 145902300
• Report Number: 2125050-2019-00388
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487429
• UDI-Public: 05708932487429
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: E179242400
• Device Catalogue Number: E17924
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/03/2019
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR