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

Model Number	5206502400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, months after the implant of the device, the patient noticed the implant had deflated (the event was observed in september 2019).Another torosa was implanted.
Additional Manufacturer Narrative
This follow-up was created to document the conclusion of the investigation.One testicular device was received for evaluation.Examination and testing of the returned device revealed a separation in the shell of the testicular near the midline.Testing revealed this to be a site of leakage.Microscopic examination of the separation revealed it to have a central groove, indicating contact with sharp instrumentation such as a needle.The injection port was confirmed to contact a needle stick, indicating the device had most likely been filled during the implant procedure.Because this component was released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the testicular shell occurred subsequent to the device packaging being opened.Confirmation of a needle stick was noted in the injection port, indicating the device most likely was filled during the implant procedure.Based on the evaluation and information received, it was concluded that the separation may have occurred inadvertently during the implant procedure.The information received did not indicate how long the device was implanted prior to noting the reported deflation.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, nonconformances and capas revealed no trends for this lot.

• Brand Name: TOROSA SALINE TESTICULAR LARGE
• Common Device Name: SALINE FILLED TESTICULAR PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9497735
• Report Number: 2125050-2019-01138
• Device Sequence Number: 1854176
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: Lay User/Patient
• Device Model Number: 5206502400
• Device Catalogue Number: 520650
• Device Lot Number: 4729276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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: 58 YR