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

Model Number 5177701400

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.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 broken pump bulb.The top of the pump bulb displayed a straight line fracture.The pump was explanted and replaced with another pump.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan pump was received for evaluation.Examination and testing of the returned component revealed a separation in the pump bulb between the first and second rib.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.Not all tests could be performed due to the separation noted.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was most likely exerted on the pump bulb to separate the site while in-vivo.A separation of this type would 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.

• Brand Name: TITAN PUMP
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9467947
• MDR Text Key: 170721000
• Report Number: 2125050-2019-01133
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932319621
• UDI-Public: 05708932319621
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5177701400
• Device Catalogue Number: 517770
• Device Lot Number: 6891647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR