MAUDE Adverse Event Report: TITAN; INFLATABLE PENILE PROSTHESIS

Model Number ES89182400

Device Problem Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.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 available information, the reservoir of this device migrated out of the left side of the patient's abdomen.The reservoir was replaced and the rest of the device was intact with no issues.No adverse patient effects were reported.

Event Description

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

Manufacturer Narrative

According to the available information this inflatable penile prosthesis was implanted on (b)(6) 2020 and revised on (b)(6) 2021 due to the reservoir herniated out of left side.The reservoir was replaced in the left in the space of retziuos.The cylinders remained were not removed.The explanted prosthesis was not returned for evaluation.Because examination may not conclusively confirm or disprove the report of migration, quality accepts the physician¿s observations of such as 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, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN
• Type of Device: INFLATABLE PENILE PROSTHESIS
• MDR Report Key: 11339565
• MDR Text Key: 232252061
• Report Number: 2125050-2021-00152
• Device Sequence Number: 1
• Product Code: JCW
• UDI-Device Identifier: 05708932487344
• UDI-Public: 05708932487344
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89182400
• Device Catalogue Number: ES8918
• Device Lot Number: 7150027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR