MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH; INFLATABLE PENILE PROSTHESIS

Model Number ES29201022

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

According to available information, this device required revision due to the pump needing to be repositioned.It was noted the reservoir of the device was somewhat superficial and needs repositioning, the pump component in the scrotum was sitting a little bit high.There also is a possibility of infection.The revision was scheduled but it is unknown if the surgery has occurred.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and 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

Additional information received indicated the pump had been repositioned due to migration.No portions of the device were explanted.

Manufacturer Narrative

Additional review determined portions of this event were also reported under manufacturer report number 2125050-2022-00573; any additional information received will be submitted under this manufacturer report number, 2125337-2022-00002.The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of repositioning and infection, coloplast accepts the physician¿s observations of such as the reason for surgical intervention.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14465608
• MDR Text Key: 294774930
• Report Number: 2125337-2022-00002
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES29201022
• Device Catalogue Number: ES2920
• Device Lot Number: 7776580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male