MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

Device Problem Device Handling Problem (3265)

Patient Problem Edema (1820)

Event Type  Injury  

Manufacturer Narrative

No manufacturer investigation was undertaken since this was a foreseen risk in device usage and is clearly noted both in the ifu and the training program.We have attached a copy of the ifu with the relevant text highlighted.

Event Description

Patient attempted self removal causing edema and was referred to surgical circumcision.

• 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 ; 97994949
• MDR Report Key: 6355951
• MDR Text Key: 68209388
• Report Number: 3011215095-2017-00919
• 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: user facility
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• 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: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 31 YR