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

Model Number 5177701400

Device Problems Crack (1135); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to available information, this device was explanted and replaced due to an unspecified malfunction.

Manufacturer Narrative

A titan pump was received for analysis.A separation was noted in the pump body.This was a site of leakage.The surfaces appeared to be rough and irregular, indicating stress was exerted.It was concluded that the rough and irregular surfaces associated with this separation indicate that sufficient stress(s) may have been exerted on the pump body to separate the site while in-vivo.A separation of this type could then allow the loss of fluid, making the device inoperable.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.

Event Description

Additional information received further reported that there was a crack in the pump bulb.The pump was implanted for less than two years.

• Brand Name: TITAN
• 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: 12640195
• MDR Text Key: 276659031
• Report Number: 2125050-2021-01493
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487429
• UDI-Public: 05708932487429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5177701400
• Device Catalogue Number: E17924
• Device Lot Number: 4605019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male