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

Catalog Number ES2916

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 08/04/2023

Event Type  Injury  

Event Description

According to the available information, the patient underwent implant while being on lovenox and, despite a drain being placed, developed a hematoma and blackening of the penis and scrotum by the next day.Hemoglobin dropped from 13 to 10.The patient was discharged the day after implant and experienced more bleeding at home with continuation of lovenox.

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Manufacturer Narrative

The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of hematoma, quality accepts the physician¿s observations.A clinical assessment confirmed, lovenox is a blood thinner.Anticoagulants can increase the risk of bleeding complications with surgical procedures even as they are intended to reduce the risk of dvt or other ischemic events.The doctor's message indicates knowledge of the challenge with blood thinner and surgery.Major bleeding episodes following prophylactic administration for abdominal and colorectal surgery (ipp implant not specified) were reported in clinical trials per lovenox labeling.It was concluded to be reasonably possible that lovenox and/or the implant procedure contributed to the postop bleeding event.Hematoma, hemorrhage, and bleeding are known and labeled complications of the titan implant procedure.The ifu indicates in the precautions, "it is the responsibility of the physician to advise the prospective patient prior to surgery, of the precautions associated with the use of this product and the associated surgical risks".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.

Event Description

According to the available information the titan touch was implanted on (b)(6) 2023 and next day it was noted patient had hematoma formation.Doctor was happy with dissection and surgery.Cardiology insisted on patient being on lovenox, so despite placing a drain, he had a huge hematoma and blackening of penis and scrotum by the next day.Hemoglobin dropped from 13 to 10.Patient was discharged (august 4th), more bleeding occurred at patient's home with continuation of lovenex.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Type of Device: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17576764
• MDR Text Key: 321474941
• Report Number: 2125050-2023-00987
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ES2916
• Device Lot Number: 9095435_ES29162400
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male