MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxemia (2207)

Event Date 09/04/2016

Event Type  Death  

Manufacturer Narrative

Prepex is not sold nor used in the united states and as a result the company has not reported to date.However, the company was requested by the fda to begin reporting as a result there is a gap between the time of the vent and the initial report.Device unavailable.

Event Description

Prepex placement: (b)(6) 2016.Prepex removal: (b)(6) 2016.Patient admitted to hsopital on (b)(6) 2016 and died, most proabaly of tetanus.

Manufacturer Narrative

Prepex is not sold nor used in the united states and as a result the company has not reported to date.However, the company was requested by the fda to begin reporting as a result there is a gap between the time of the vent and the initial report.The company has revised the ifu to include warnings regarding the use of the device in a population that has not been properly immunized for tetanus.Device unavailable.

Event Description

Prepex placement: (b)(6) 2016.Prepex removal: (b)(6) 2016.Patient admitted to hospital on (b)(6) 2016 and died, most probably of tetanus.

• Brand Name: PREPEX
• Type of Device: PREPEX
• Manufacturer (Section D): CIRC MEDTECH; 1 hanagar st.; hod hasharon, 45013 05; IS 4501305
• Manufacturer (Section G): 3BY; tefen industrial zone; tefen, 24959 ; IS 24959
• Manufacturer Contact: ossie milanov ; 1 hanagar st.; hod hasharon, 45013-05 ; IS 4501305 ; 52 8618898
• MDR Report Key: 6137395
• MDR Text Key: 61186468
• Report Number: 3011215095-2016-00876
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• PMA/PMN Number: K103695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 45 YR