MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

Device Problems Device Contamination With Biological Material (2908); Insufficient Information (3190)

Patient Problem Toxemia (2207)

Event Date 04/03/2016

Event Type  Death  

Manufacturer Narrative

Prepex is not sold nor used in the usa,therefore the manufacturer has not reported to date.However, the company was requested by the fda to begin reporting and has done such.This has created a gap between the date of event and the initial report.Device not available.

Event Description

Prepex placement: (b)(6) 2016.Prepex removal: (b)(6) 2016.On (b)(6) 2016 patient was admitted to hospital and diagnosed with tetanus from which he died.

Manufacturer Narrative

Prepex is not sold nor used in the usa,therefore the manufacturer has not reported to date.However, the company was requested by the fda to begin reporting and has done such.This has created a gap between the date of event 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 not available.

Event Description

Prepex placement: (b)(6) 2016.Prepex removal: (b)(6) 2016.On (b)(6) 2016 patient was admitted to hospital and diagnosed with tetanus from which he died.

• 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: 6137392
• MDR Text Key: 61186695
• Report Number: 3011215095-2016-00712
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: RW
• PMA/PMN Number: K103695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• 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: 34 YR