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

Model Number 5206502400

Device Problems Leak/Splash (1354); Defective Device (2588); Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 08/02/2017

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 of 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, on examination of the implant, the surgeon noticed a mark on filling the implant.The prosthesis started to leak at this defective mark.Additional information received 08/31/2017: procedure not completed successfully.

Manufacturer Narrative

One torosa device was received for evaluation.Examination and testing of the returned component revealed a separation between the mid line and injection port on the shell of the device.Testing revealed this to be a site of leakage.Microscopic examination of the surface revealed a small separation with a central groove indicating the area was in contact with a small sharp instrument such as a needle.Because this component was released according to manufacturing and quality control procedures, quality concluded that the observed instrument damage on the testicular shell occurred subsequent to the device packaging being opened, most likely during the prepping/filling of the device for surgery.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

• Brand Name: TOROSA SALINE TESTICULAR LARGE
• Type of Device: TESTICULAR PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 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: 6883814
• MDR Text Key: 86983996
• Report Number: 2125050-2017-00433
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5206502400
• Device Catalogue Number: 5206502400
• Device Lot Number: 5675338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR