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

Model Number	5206502400
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TESTICULAR PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6883814
• Report Number: 2125050-2017-00433
• Device Sequence Number: 16323189
• Product Code: FAF
• UDI-Device Identifier: 05708932470858
• UDI-Public: 05708932470858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR