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

Catalog Number	ER8075
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the label on the inner package of the kit claims that the device is a '125 cc titan cl reservoir', but the device is a 75 cc reservoir.All of the lot numbers on the box, inner packaging, and device match and represent a 75cc titan cl reservoir device, but the label on the inner package incorrectly states that it is the larger titan reservoir (125cc).The device was not implanted.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report [nc] and capa.Devices met specification prior to release.No trends were noted for complaints and there were no capas that were confirmed in veeva to be associated.A nc was identified as associated with this lot number; however, the failure being reported in the complaint is not related to the issue identified in the nc.The device was not returned for evaluation.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the label on the inner package of the kit claims that the device is a '125 cc titan cl reservoir', but the device is a 75 cc reservoir.All of the lot numbers on the box, inner packaging, and device match and represent a 75cc titan cl reservoir device, but the label on the inner package incorrectly states that it is the larger titan reservoir (125cc).The device was not implanted.
Additional Manufacturer Narrative
The pictures submitted from the field for (b)(4) were reviewed by quality.For the lot 10107594 complaint unit, the correct retail label and laser marked lot number were pictured.No picture of the patient labels were provided.It was confirmed that the pictured lid printing incorrectly references 125cc titan reservoir instead of 75cc, but the lot number and expiration date on the lid printing were correct.The dhr for lot 10107594 was reviewed.There were no nc's or capa's tied to lot 10107594.Lid printing was performed per internal procedures.Afterwards lid independent inspection was completed per internal procedures.There was no units rejected during this inspection.The secondary copy of the lid was attached to the traveler and contained the correct printed information (75cc).The patient label and retail label attached to the traveler were also correct.Given the information collected during investigation, a root cause for the issue noted in the complaint was not identified as no discrepancies were found during dhr review.Based on the available information, a root cause for the issue noted in the complaint was not identified as no discrepancies were found during dhr review.Given this is the only complaint of this issue on this lot, it is believed to be an isolated incident.

• 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: 21941755
• Report Number: 2125050-2025-00733
• Device Sequence Number: 15591935
• Product Code: FHW
• UDI-Device Identifier: 05708932473910
• UDI-Public: 05708932473910
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: ER8075
• Device Lot Number: 10107594_ER80752400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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