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

Model Number EN89182400

Device Problem Failure to Cycle (1142)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/21/2020

Event Type  malfunction  

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

Event Description

According to the available information, though not verified, malfunction: was not cycling and patient was experiencing pain.The device was revised.

Event Description

According to the available information this inflatable device was implanted on (b)(6) 2019 and revised on (b)(6) 2020 due to malfunction.Additional information received from the clinical sales representative indicated: ¿malfunction: was not cycling and patient was experiencing pain.¿ a titan pump was received for evaluation.Examination and testing of the returned components revealed no functional abnormalities.The information received indicated the device was not cycling, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.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.

Manufacturer Narrative

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.

• Brand Name: TITAN
• Type of Device: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10723566
• MDR Text Key: 212707160
• Report Number: 2125050-2020-00993
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932072649
• UDI-Public: 05708932072649
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EN89182400
• Device Catalogue Number: EN8918
• Device Lot Number: 6778977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 12/03/2020
• Patient Sequence Number: 1
• Patient Age: 71 YR