MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 16CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29162400

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Information (3190)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

According to the available information, the patient noted to have auto-inflation of the device.The physician found pump high riding and bothersome with intercourse.The device was replaced approximately one month after implantation.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation and the additional event information.Quality was unsuccessful in securing the device for evaluation.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.However, because quality's examination may not conclusively confirm or disprove the report of malposition, quality accepts the physician's observations of such as the reason for surgical intervention.Because identification numbers were not provided, quality was unable to trace device lot history of the device, complaint history, non-conformances, and capas for this lot number.However, all devices sold and labeled by this corporation must pass manufacturing, quality, and sterility procedures prior to release.

Event Description

Additional information received indicated the item and lot # are unavailable and the device is not available for evaluation.Medwatch # mw5080803.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 16CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8061609
• MDR Text Key: 126914454
• Report Number: 2125050-2018-00808
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539173
• UDI-Public: 05708932539173
• 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,other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29162400
• Device Catalogue Number: ES2916
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 47 YR
• Patient Weight: 93