MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR NAR SCRO 16CM; INFLATABLE PENILE PROSTHESIS

Model Number QNR9161022

Device Problem Extrusion (2934)

Patient Problem Erosion (1750)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

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, erosion/extrusion.Pump exposure to scrotum.

Manufacturer Narrative

Quality was unsuccessful in securing the explanted prosthesis for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.However, because quality's examination may not conclusively confirm or disprove the report of erosion/extrusion, quality accepts the physician's observations of such as the reason for surgical intervention.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.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, and because the device is not available for evaluation, no further corrective action is required at this time.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan otr pump, two cylinders, and a reservoir were received for evaluation.Examination of the returned components revealed no abnormalities that would have contributed to the report of erosion.However, because quality's examination of the returned components may not conclusively confirm or disprove the report of erosion, quality accepts the physician's observations of such as the reason for surgical intervention.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.A review of the complaint history database revealed no other complaints for lot 5258474.Review of nonconforming reports revealed no nonconformance's that relate to the reported complaint for this lot.No capas are associated with this lot.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 OTR NAR SCRO 16CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7466240
• MDR Text Key: 106696251
• Report Number: 2125050-2018-00310
• 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,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QNR9161022
• Device Catalogue Number: QNR9161022
• Device Lot Number: 5258474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR