MAUDE Adverse Event Report: TESTOPEL TROCAR DEVICE; TESTOPEK TROCAR DEVICE

Lot Number P1410

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  Injury  

Event Description

Patient reports that a few of the pellets have come out after the procedure."ongoing".Name and strength: testopel 15mg.Dose or amount: 75 mg.Frequency: qum.Route: sq.Dates of use: (b)(6) 2015 - ongoing.

• Brand Name: TESTOPEL TROCAR DEVICE
• Type of Device: TESTOPEK TROCAR DEVICE
• MDR Report Key: 6092432
• MDR Text Key: 59765965
• Report Number: MW5065955
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 66887000410
• UDI-Public: 66887-0004-10
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/07/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Lot Number: P1410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR