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

Model Number ES89222400

Device Problems Break (1069); Material Erosion (1214); Fluid/Blood Leak (1250); Inflation Problem (1310); Material Rupture (1546)

Patient Problems Emotional Changes (1831); Pain (1994); Skin Erosion (2075); Discomfort (2330); Genital Bleeding (4507); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, the patient with this device stated that this device had an unspecified failure.No adverse patient effects were reported.

Manufacturer Narrative

The following h6 codes were previously applied in error: a040503 material erosion, e1407 genital bleeding, e1718 skin erosion, b11 historical data analysis, b14 analysis of production data, and b12 trend analysis.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 information 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 further reported that there appeared to be a leak, as the patient's scrotum swelled up and then resolved.The prosthesis would not inflate or deflate.The patient also had a concern that the tubing appeared to be too distal, and it interfered on the left side with the prosthesis when he was intimate.The patient also had a hernia repair on an unknown date, and was having some discomfort from the reservoir.The patient underwent a revision.During the procedure it was observed that there was clearly a break and all fluid had leaked out.The break point was at the base of the cylinder; the cylinders and pump were replaced.

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

Event Description

According to available additional information, this device was explanted and replaced due a broken reservoir, which caused leakage into the scrotum.The patient experienced swelling and pain.Additionally, it was reported that the patient has suffered mental anguish, loss of capability for the enjoyment of life, has incurred medical treatment of such injuries.

• 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: 11811933
• MDR Text Key: 250193012
• Report Number: 2125050-2021-00503
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539128
• UDI-Public: 05708932539128
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES89222400
• Device Catalogue Number: ES8922
• Device Lot Number: 6945908
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• Date Device Manufactured: 06/24/2021
• 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): Hospitalization; Required Intervention
• Patient Sex: Male