MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

Device Problem Device Handling Problem (3265)

Patient Problem Edema (1820)

Event Date 10/21/2016

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.

Event Description

Patient attempted to self remove device leading to 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: 6355952
• MDR Text Key: 68209640
• Report Number: 3011215095-2017-00920
• 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: 28 YR