MAUDE Adverse Event Report: COLOPLAST A/S TOROSA SALINE TESTICULAR LARGE; SALINE FILLED TESTICULAR PROSTHESIS,

Model Number 5206502400

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2016

Event Type  malfunction  

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

Testicular was noted leaking when 80% of the implant was filled, as per protocol.Bilateral restoration was not possible, surgeon placed one implant, closed the other site.Patient will undergo a secondary procedure to place other implant.

Manufacturer Narrative

This follow-up mdr was created to document the evaluation of the returned device as follows: one torosa saline testicular implant was received for evaluation.Examination and testing of the returned device identified a point of leakage on the shell of the device, as reported.Microscopic examination of the site revealed a small hole with a central groove, indicating it was caused by contact with a small sharp instrument such as a needle.Signs of the separation are more apparent on the inside of the shell indicating that the insertion point of the needle was on the inside of the implant.It was also noted that the location of the separation is consistent with where the end of the needle would be during filling.Based on these observations, it was concluded that the inside of the device came into contact with the needle used for filling the device during filling which caused the separation and subsequent leakage.This instrument damage to the device during preparation is associated with the root cause of the failure.

• Brand Name: TOROSA SALINE TESTICULAR LARGE
• Type of Device: SALINE FILLED TESTICULAR PROSTHESIS,
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5470505
• MDR Text Key: 39700172
• Report Number: 2125050-2016-00018
• Device Sequence Number: 1
• Product Code: FAF
• UDI-Device Identifier: 05708932470858
• UDI-Public: 05708932470858
• Combination Product (y/n): N
• PMA/PMN Number: P020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5206502400
• Device Catalogue Number: 5206502400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention