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

Catalog Number	ES8924
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to available information, physician used their first 24 reconnected device.The patient measured 14 distally and 11 proximally.The physician used a 24cm implant with 1cm rear tip extenders.Physician ended up needing to trim 2.9cm off one side of the tubing and 2.4cm off the other.He feels like the tubing is too long and will continue to use non-preconnected as long as it remains available or until the preconnected tubing is shortened.
Additional 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 that the 24 pre-connect tubing would have been too long for this patient's anatomy, quality accepts the physician¿s observations.The tubing length specification has been validated as part of the design via clinical data and clinician feedback (see (b)(4) for further details).The overall occurrence rate of this type of feedback remains low but will continue to be monitored.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Common Device Name: 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: 23006445
• Report Number: 2125050-2025-01429
• Device Sequence Number: 18770905
• Product Code: FHW
• UDI-Device Identifier: 05708932768139
• UDI-Public: 05708932768139
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: ES8924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown