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

Model Number 5177502400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete.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, titan touch pump was replaced due to locked pump.

Manufacturer Narrative

A titan touch pump was received for evaluation.Examination and testing of the returned component revealed no functional or visual abnormalities with the pump.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no additional complaints of this type for lot 4893225.Because the available information did not indicate what factors may have contributed to the reported event of "locked pump," and because no functional abnormalities were noted, quality cannot determine the true cause of this reported event.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.

• Brand Name: TITAN TOUCH PUMP
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7487727
• MDR Text Key: 107378493
• Report Number: 2125050-2018-00348
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932533966
• UDI-Public: 05708932533966
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5177502400
• Device Catalogue Number: 5177502400
• Device Lot Number: 5159764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR