MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR NAR SCRO 18CM; INFLATABLE PENILE PROSTHESIS

Model Number QNR9181022

Device Problems Contamination /Decontamination Problem (2895); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.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 the available information, there was a malfunction of the lockout valve and pump.The pump was not able to pump due to foreign substances, and the fluid in the reservoir didn't flow due to malfunction of the valve.The pump and reservoir were replaced.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.A photo was provided of the device after explant.The photo evaluation was determined to be inconclusive.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, nonconformance's and capas revealed no trends for this lot.The device was not received for evaluation.Review of the photo was inconclusive and without the benefit of testing or microscopic examination of the device, quality cannot confirm what may have contributed to the noted malfunction.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.

• Brand Name: TITAN OTR NAR SCRO 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8972190
• MDR Text Key: 156824356
• Report Number: 2125050-2019-00726
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QNR9181022
• Device Catalogue Number: QNR918
• Device Lot Number: 5361923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR