MAUDE Adverse Event Report: CIRC MEDTECH PREPEX

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Toxemia (2207)

Event Date 09/01/2014

Event Type  Death  

Manufacturer Narrative

Key observations: patient used different names during smc and during illness; patient was circumcised from (b)(6) but died from a neighboring district, (b)(6); he was (b)(6); resident in a semi-permanent house with a mud floor , and co-resident with his mother; (b)(6) also indicated that the hygiene and sanitation at his mother's home was poor; on day 9 ( 2 days after device removal) he notified the (b)(6) about a mild fever; no information on history of immunization, or infestation history with jiggers; at time of death, hospital indicates that wound was septic, although while at circumcising district during device removal the wound was clean, and mentioned no use of any traditional herbs, and no known wound; he resumed work ((b)(6)) and washed his body in swampy dirty water; died on 13th day after smc with diagnosis as tetanus, in a neighboring district; he was the 8th patient to die of tetanus in (b)(6) hospital in 2014.However, the previous 7 cases were not related to smc; prior to his death he is reported to have joined a culture dance ((b)(6)) for his cousin though they deny having put any local/traditional herbs on the wound; however, poor hygiene and sanitation, mud floor at his residence, and being a bricklayer may have increased this person's exposure to the risk of tetanus.Prepex is not sold nor used in the united states and as a result the company has not reported any incidents to the fda to date.However, we were required by the fda to begin reporting and as a result there is a gap in the time of incident to the time of reporting.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

Approximately two days following removal procedure which was done on (b)(6) 2014 the patient began to feel ill.He was hospitalized diagnosed as having tetanus, and died at the (b)(6) hospital in (b)(6) 2014.

Manufacturer Narrative

Key observations: patient used different names during smc and during illness; patient was circumcised from (b)(6) but died from a neighboring district, (b)(6); he was bricklayer and a subsistence farmer; resident in a semi-permanent house with a mud floor , and co-resident with his mother; (b)(6) also indicated that the hygiene and sanitation at his mother's home was poor; on day 9 (2 days after device removal) he notified the (b)(6) about a mild fever; no information on history of immunization, or infestation history with jiggers; at time of death, hospital indicates that wound was septic, although while at circumcising district during device removal the wound was clean, and mentioned no use of any traditional herbs, and no known wound; he resumed work (brick laying) and washed his body in swampy dirty water; died on 13th day after smc with diagnosis as tetanus, in a neighboring district; he was the 8th patient to die of tetanus in (b)(6) hospital in 2014.However, the previous 7 cases were not related to smc; prior to his death, he is reported to have joined a culture dance ((b)(6)) for his cousin though they deny having put any local/traditional herbs on the wound; however, poor hygiene and sanitation, mud floor at his residence, and being a bricklayer may have increased this person's exposure to the risk of tetanus.Prepex is not sold nor used in the united states and as a result, the company has not reported any incidents to the fda to date.However, we were required by the fda to begin reporting and as a result, there is a gap in the time of incident to the time of reporting.Device not available.

Event Description

Approximately two days following removal procedure which was done on (b)(6) 2014, the patient began to feel ill.He was hospitalized diagnosed as having tetanus, and died at the (b)(6) hospital in (b)(6) 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 ; 528618898
• MDR Report Key: 6137369
• MDR Text Key: 63266115
• Report Number: 3011215095-2016-00474
• 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: 12/01/2016

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2014
• 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: 0
• Patient Outcome(s): Death
• Patient Age: 19 YR