MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

Device Problem Insufficient Information (3190)

Patient Problem Toxemia (2207)

Event Date 10/02/2014

Event Type  Death  

Manufacturer Narrative

Patient's age and name was different at (b)(6) where he died.Delayed death notification, which occurred 18 days after his death; patient was (b)(6).Although patient had a girlfriend,they were not staying together and she was not mentioned as the next of kin.No mention/documentation of smc was made at the 2 clinics that first got in contact with the patients, until he got to (b)(6) hospital.Patient's tribe and religion were not documented; these may be important to track behavioral post-op.This case appears to have protocol deviation, having (b)(6) person circumcised with prepex.Unfortunately no documentation on wound, although he was staying in a (b)(6) in the peripherals and riding a (b)(6) which may have exposed him to the risk of injuries.Prepex is not used nor sold in the united states and as a result, the company has not reported events to date.However, the company was requested by the fda to begin reporting.As a result, there is a gap between the time of the event and the initial report.Device was not available.

Event Description

Patient underwent prepex placement on (b)(6) 2014, he requested early removal on (b)(6) 2014.Shortly after he was admitted to the hospital with tetanus and died on (b)(6) 2014.

Manufacturer Narrative

Patient's age and name was different at (b)(6) where he died: delayed death notification, which occurred 18 days after his death; patient was (b)(6), on haart with cd4 cell count of 600; although patient had a girlfriend they were not staying together and she was not mentioned as the next of kin; no mention/documentation of smc was made at the 2 clinics that first got in contact with the patients, until he got to (b)(6) hospital; patient's (b)(6) were not documented; these may be important to track behavioral post -op; this case appears to have protocol deviation, having an hiv+ person circumcised with prepex.Unfortunately no documentation on wound, although he was staying in a (b)(6) which may have exposed him to the risk of injuries.Prepex is not used nor sold in the united states and as a result the company has not reported events to date.However, the company was requested by the fda to begin reporting.As a result there is a gap between the time of the event and the initial 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.Device not available.

Event Description

Patient underwent prepex placement on (b)(6) 2014, he requested early removal on (b)(6) 2014.Shortly after he was admitted to the hospital with tetanus and died on (b)(6) 2014.

• 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: 6137371
• MDR Text Key: 61187095
• Report Number: 3011215095-2016-00476
• 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: 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

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/25/2016
• 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): Death
• Patient Age: 32 YR