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

Catalog Number ES2922

Device Problems Migration (4003); Failure to Deflate (4060)

Patient Problems Erosion (1750); Inflammation (1932); Pain (1994); Fibrosis (3167)

Event Type  Injury  

Event Description

According to available information, this device required explantation due to difficult inflation.The patient reported pain and difficult inflation 3 weeks after implant.The doctor tried and was not able to unblock the pump.Replacement surgery was scheduled and before the surgery the patient reported he could see the cylinders.The patient had a huge fibrosis around the pump and an enlarged scrotum.Once the pump was out, it started to work.No other adverse patient effects were reported.

Manufacturer Narrative

The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release and 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.Implant information given was (b)(6) 2023, therefore, (b)(6) 2023 used as the implant date.

Manufacturer Narrative

A picture was provided; however, without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.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 was revised due to the patient having a lot of pain and the ipp didn't work well : staying active all time and he had difficult to deflate with the one-touch pump.One week before the explant, the patient called him telling about a very bad situation: he could see the cylinders.He had a huge fibrosis around the pump, and a huge enlargement of the scrotum.

• 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: 17358759
• MDR Text Key: 319370766
• Report Number: 2125050-2023-00827
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932590419
• UDI-Public: 5708932590419
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ES2922
• Device Lot Number: 8459014_ES29221022
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 03/18/2022
• 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): Required Intervention