MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS

Model Number ES28142400

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); No Information (3190)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.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.

Event Description

According to the available information, the device was explanted due to the size.The explanted device was too small and was not sitting properly.The physician remeasured and inserted a new device.

Manufacturer Narrative

This follow-up was created to document the conclusion of the investigation.A titan touch pump, one cylinder and reservoir were received for evaluation.As examination of the device may not conclusively confirm or disprove the report of a sizing issue, pain, and malposition, quality accepts the physician's observations as to the reason for surgical intervention.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

Event Description

Additional information received stated, sst deformity with implant tip behind glans, reservoir in good position.Positioning resulted in pain, malposition.The explanted device was to small and was not sitting properly.The doctor remeasured and inserted a new device.

• Brand Name: TITAN TOUCH INFR ZERO ANG 14CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9649510
• MDR Text Key: 177050493
• Report Number: 2125050-2020-00087
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539104
• UDI-Public: 05708932539104
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES28142400
• Device Catalogue Number: ES2814
• Device Lot Number: 4979045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR