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

Model Number ES88202400

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 12/19/2019

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, another reservoir was implanted and repositioned.

Event Description

Additional information indicated the device was implanted around (b)(6) 2019.

Manufacturer Narrative

This follow-up mdr is created to document the additional information regarding implant/explant dates, and the conclusion of the investigation.The device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of reposition 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.No patient injury was reported.

• Brand Name: TITAN INFRA ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9628928
• MDR Text Key: 176295272
• Report Number: 2125050-2020-00073
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487245
• UDI-Public: 05708932487245
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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: ES88202400
• Device Catalogue Number: ES8820
• Device Lot Number: 6741633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR