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

Model Number	5206302400
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/10/2018
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, implant was migrating, had been tied down at surgery and once incision was made, implant surface.The tied down tab was broken.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.One torosa testicular implant was received for evaluation.Examination and testing of the returned components revealed a separation in the suture tab of the prosthesis.Testing revealed this not to be a site of leakage.The separation appears to be rough and irregular, indicating sufficient stress was exerted.Based on the information received and quality's examination, quality concludes that stress was exerted on the suture tab of the prosthesis due to the tied suture, causing separation in the tab.This could then allow for the testicular implant to move from its intended position.Quality cannot determine when this separation occurred.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no additional complaints for lot 4083537.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.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 MED
• Common Device Name: SALINE FILLED TESTICULAR PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7500406
• Report Number: 2125050-2018-00360
• Device Sequence Number: 1718566
• Product Code: FAF
• UDI-Device Identifier: 05708932470834
• UDI-Public: 05708932470834
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: 5206302400
• Device Catalogue Number: 5206302400
• Device Lot Number: 4083537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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: 43 YR