MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89202400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Seroma (2069); Discomfort (2330)

Event Date 10/21/2019

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, the pump of the inflatable device was explanted due to a hematoma.Per surgical report, seroma of genitourinary system after genitourinary system procedure, s/p insertion of penile implant.The patient experienced tenderness in the scrotal area, leading to the decision to remove the pump.There was no complaint on the device.Another inflatable pump was implanted.

Manufacturer Narrative

This follow up mdr is created to document the conclusion of the investigation.A titan pump was received for evaluation.As examination of the device may not conclusively confirm or disprove the report of hematoma quality accepts the physician's observations as to the reason for surgical intervention.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 SCROTAL ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9413662
• MDR Text Key: 169197143
• Report Number: 2125050-2019-01078
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487368
• UDI-Public: 05708932487368
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89202400
• Device Catalogue Number: ES8920
• Device Lot Number: 6565102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR