MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

Device Problems Device Dislodged or Dislocated (2923); Device Handling Problem (3265)

Patient Problem Edema (1820)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

Device displacement or dislodgement will occur when patient moves the device in some manner contrary to instructions and counseling given on the day of placement.The information as to how the event occurred is often unavailable.Prepex is sold and used in (b)(6), it is neither sold nor used in the usa.Receiving reports regarding aes is very challenging and the company makes every effort to gain as much information as possible.The company did not begin reporting any aes to the fda until it was demanded by the fda.As a result there is a gap between the time of the ae and the reporting.This issue will resolve itself during 2017 when the company will report to the fda as required and requested.Device unavailable.

Event Description

Device dislodgement, reason unknown, leading to edema, patient referred to surgicial circumcision.

Manufacturer Narrative

Device displacement or dislodgement will occur when patient moves the device in some manner contrary to instructions and counseling given on the day of placement.The information as to how the event occurred is often unavailable.Prepex is sold and used in (b)(6), it is neither sold nor used in the usa.Receiving reports regarding aes is very challenging and the company makes every effort to gain as much information as possible.The company did not begin reporting any aes to the fda until it was demanded by the fda.As a result there is a gap between the time of the ae and the reporting.This issue will resolve itself during 2017 when the company will report to the fda as required and requested.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

Device dislodgement, reason unknown, leading to edema; patient 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: 6165360
• MDR Text Key: 62080293
• Report Number: 3011215095-2016-00873
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 12/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2016
• Initial Date FDA Received: 12/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 32 YR