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	09/07/2018
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, torosa became deflated.No holes could be identified upon explant.
Event or Problem Description
Additional information received from the tm indicated the device was filled according to the ifu at the time of implanted.The patient did experience fluid buildup in the scrotum around the implant area.About half of the fluid was still inside the implant at the time of explant with no noticeable holes or damage.The patient was a double torosa implant at the same time and the other implant was doing just fine.
Additional Manufacturer Narrative
The device was received in free formalin liquid making device handling and evaluation impossible.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the device.If additional information is received, quality will re-evaluate this complaint in accordance with procedures.Because identification numbers were not provided, quality was unable to trace device lot history of the device, complaint history, non-conformance's, and capas for this lot number.However, all devices sold and labeled by this corporation must pass manufacturing, quality, and sterility procedures prior to release.

• 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: 7957574
• Report Number: 2125050-2018-00744
• Device Sequence Number: 940904
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 5206502400
• Device Catalogue Number: 520650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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: 31 YR