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

Model Number ES29202400

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Date 07/12/2019

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.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, added reservoir fluid; pump exchanged.

Event Description

Per additional information received: malposition of pump, infection.The device was replaced but will not be available for return.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information, implant date, corrected device information, and the conclusion of the 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 becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.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, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8880323
• MDR Text Key: 153872391
• Report Number: 2125050-2019-00645
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932533966
• UDI-Public: 05708932533966
• 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: 10/02/2019

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: ES29202400
• Device Catalogue Number: ES2920
• Device Lot Number: 6467934
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR