MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxemia (2207)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

Prepex is not used nor sold in the united states and as a result the manufacturer has not reported any events to date.The fda demanded the company begin reporting which the company has creating a gap between the date of event and the report.

Event Description

Prepex placement: (b)(6) 2015.Prepex removal: (b)(6) 2015.Patient began showing early symptoms of tetanus on (b)(6) 2015.Patient had full recovery.

Manufacturer Narrative

Prepex is not used nor sold in the united states and as a result the manufacturer has not reported any events to date.The fda demanded the company begin reporting which the company has creating a gap between the date of 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: (b)(6) 2015.Prepex removal: (b)(6) 2015.Patient began showing early symptoms of tetanus on (b)(6) 2015.Patient had full recovery.

• 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: 6137380
• MDR Text Key: 61192138
• Report Number: 3011215095-2016-00587
• 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: 11/30/2016

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
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2015
• 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): Life Threatening
• Patient Age: 39 YR