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

Catalog Number E17924

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

According to the available information during implant of the ipp, the doctor noticed a flaky coating that may have rubbed off the cylinder.The cylinders came to the doctor out of the soak, and she noticed a line that didn't have the abx color.She then injected more with syringe and rubbed it in and that is when she noticed the flaky appearance and texture.Upon further rubbing, the texture came off and cylinders had the abx color.Ultimately, the doctor proceeded with the implant as is and coating was uniform.Additional clarification was received indicating that the flaky coating appeared to be excess coating and the cylinders still absorbed the solution it was soaked inn.There was not absence of coating, just extra.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.

• 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: 18261849
• MDR Text Key: 329669356
• Report Number: 2125050-2023-01514
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487429
• UDI-Public: 05708932487429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E17924
• Device Lot Number: 9331246_E179242400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Date Device Manufactured: 09/07/2023
• 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 Age: 65 YR
• Patient Sex: Male