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

Model Number	5206502400
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/18/2018
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, the patient had to return due to a flat implant done about a month prior.The old implant was removed and was completely flat with no fluid.Upon filling it to check for leaks, none were identified.A new implant was placed.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.One testicular was received for evaluation.Upon return of the device it was received with fluid inside and a butterfly needle was injected to drain the fluid prior to sterilization.The device was submerged in water, but no leakage was noted.Microscopic examination of the injection port revealed two separations, indicating the injection port was punctured twice.Examination and testing of the testicular post sterilization revealed no functional abnormalities.Therefore, quality cannot confirm the complaint as reported.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with 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: 8248320
• Report Number: 2125050-2019-00022
• Device Sequence Number: 13851405
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: Health Professional
• Device Model Number: 5206502400
• Device Catalogue Number: 520650
• Device Lot Number: 6336762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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: 26 YR