MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

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

Patient Problems Death (1802); Toxemia (2207); Toxemia (2207)

Event Date 05/21/2016

Event Type  Death  

Manufacturer Narrative

Prepex is not sold nor used in the united states, as a result the manufacturer has not reported events to date.However, upon request by the fda the manufacturer is now reporting events which has created a gap between the initial event and the 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.The ifu is attached with the relevant text highlighted.

Event Description

Prepex placement on (b)(6) 2016.Prepex removal on (b)(6) 2016.Patient admitted to hospital on (b)(6) 2016.Mc wound appeared clean, necrotic sores on both feet were observed.

Manufacturer Narrative

Prepex is not sold nor used in the united states, as a result the manufacturer has not reported events to date.However, upon request by the fda the manufacturer is now reporting events which has created a gap between the initial event and the report.Device not available.

Event Description

Prepex placement (b)(6) 2016; prepex removal (b)(6) 2016.Patient admitted to hospital on (b)(6) 2016.Mc wound appeared clean, necrotic sores on both feet were observed.

• 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: 6137391
• MDR Text Key: 65681773
• Report Number: 3011215095-2016-00811
• 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

2 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: 06/14/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 18 YR