| Model Number N/A |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Toxemia (2207)
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| Event Date 06/03/2014 |
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Event Type
Injury
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Manufacturer Narrative
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The following report was received from (b)(6): introduction: the present case reports describes a two months follow-up for a case of generalized tetanus that occurred during the healing period of a circumcised client successfully managed by clinicians in (b)(6) hospital.The purpose of this report is to describe the case and its probable association with a post-circumcision wound or any other lesions and provide recommendations on preventive measures to avoid similar cases case report: the patient permission for print and electronic publication was obtained before reporting.A (b)(6) year-old man, farmer living in a rural area in (b)(6) has been received at (b)(6) district hospital on (b)(6) 2014, at 4:00 p.M., complaining of muscle spasms localized in his back, face, upper limbs and lower limbs.Tetanus immediately came to the top of the list of differential diagnoses.Upon further history, the patient reported that he had not received tetanus immunization in the past.On (b)(6) 2014, the patient had presented to a voluntary medical male circumcision (vmmc) clinic that uses the prepex¿ device to undergo circumcision.When he arrived at the clinic, he was offered (b)(6) testing and tested (b)(6).Following the prepex-based male circumcision protocol, he was screened and found no contraindication for circumcision by prepex and was offered the service the same day, (b)(6).The client was given post-placement instruction, translated in the local language, on how to care for the wound and was also advised to return for removal of the dead foreskin to complete the service.Prepex removal was done on (b)(6) 2014.The service was provided during the vmmc campaign in (b)(6) health centre that aimed to circumcise 3,000 men in 4 weeks.(b)(6) health center is a clean, well-kept facility equipped with functional sterilization equipment that is used to sterilize all instruments for circumcision purposes.The placement and the removal of the prepex were performed by trained and certified health care providers and the procedures were performed under standardized aseptic conditions.Upon diagnosis of tetanus at (b)(6) hospital on (b)(6) 2014, the client was given procaine penicillin: 2 million ui/im; ceftriaxone: 1 gm; and metronidazole (flagyl): 500 mg.A peripheral intravenous line was opened and he was given 1,000 ml of ringer's lactate, 1,000 ml of normal saline and 500 ml of 10% glucose solution.Finally, he was given 3,000 ui/im of human serum tetanus immunoglobulin.The clinicians then decided to transfer the patient to (b)(6) hospital for better care, as the facility is equipped with an intensive care unit (icu) and staffed with highly trained anesthesiologists and other clinicians.On his arrival at (b)(6) on (b)(6), a physical examination revealed a patient with spasmic contractions, generalized body weakness between contractions, but fully alert and conscious, with a reading of 15/15 on the glasgow coma scale (gcs).He was hemodynamically stable with audible heart sounds but with tachycardia, blood pressure of 120/75 mmhg, heart rate 150 beats per minute, and strong palpable central and peripheral pulses.On clinical examination, he had good chest movement with sufficient/clear air entry to both lungs except for mild rhonchi in the left lung field.Oxygen saturation was 97% and his respiratory rate was 18 per minute.With the clinical diagnosis of tetanus, the care team at the military hospital also wanted to rule out the possibility of other infectious and non-infectious origins, e.G., meningitis or drug-induced spasms.Again, a thorough head-to-toe examination to identify possible tetanus spores entry was done; there were visible cracks on his feet, a clean circumcision wound, and scars on his neck and back from traditional healers who suspected meningitis.A crack on left foot of the patient: the (b)(6) team visited the patient's home.The patient lives in a typical (b)(6) rural farming home, with cattle in the compound and crops drying all around the compound.He is growing rice in a nearby swamp.After the prepex placement and removal, he continued his activities including moving around the shelter, giving mixed herbs to the cows and visiting his rice plantation.All seven of his children are immunized.The status of the mother's tetanus immunization is certain, as her youngest child is 5 years old.The patient was not immunized against tetanus.His 18-year-old son has been circumcised in the same period using prepex and he healed well.The care team decided on the following management: wound care: the wound was regularly cleaned with hydrogen peroxide twice a day and kept open.There was no necrotic tissue that needed to be removed.Medications: he received human immunoglobulin and tetanus vaccine on (b)(6) 2014; ampicillin iv 1 gm iv tid; and metronidazole iv 500 mg tid.He was also given sedatives: midazolam 6 mg per hour, which was later increased to 10 mg per hour; thiopental iv 50 to 75 mg prn; and pancuronium iv 4 mg every 3 hours.Given the increasing spasms on the upper body with trismus and the sedatives and muscle relaxants, the care team performed a tracheostomy, intubated the patient and provided mechanical ventilation using a respirator.Typical for tetanus, the signs[?]spasm and trismus[?]worsened with stimulus such as light and noise, so the client was kept in a dark and quiet room.After 3 days of care, however, on (b)(6), the patient developed a fever of 39 °c and his blood pressure started to drop; however, his other vital signs remained within the normal range the care team sent urine, blood and meningeal fluid samples to investigate the source of fever, (septic shock, malaria, and meningitis), and a swab sample was taken from the circumcision wound.The wound swab showed staphylococcus aureus.Liver and renal function tests were done, renal tests slightly elevated at admission were then within normal range, and liver tests (sgot, sgpt) both elevated.The care team pursued to investigate the reasons for the elevated liver function test.The tracheostomy site was clean and well-functioning.With a probable diagnosis of septic shock, additional antibiotics were added: on (b)(6) cefotaxime was initiated.On (b)(6), the patient's fever came down to 38 °c and his vital signs became stabilized.A try of oral feeding through a nasogastric tube on (b)(6) has not been well-tolerated and the patient was maintained on parenteral support; his temperature stayed around 38 °c.Without a clear explanation of persistent fever, a new full septic screening was rolled out on of june 16.Finally, a swab sample from tracheostomy wound revealed a klebsiella sensitive to imipenem; other samples were negatives.A combination of imipenem and metronidazole was started immediately.On (b)(6), it had been 36 hours since convulsions were observed, so a decision was made to hold off on all sedative medications.The patient presented with muscle rigidity, which could be addressed by regular physiotherapy, and he breathed spontaneously on continuous positive airway pressure mode.Meanwhile, enteral nutrition through the nasogastric tube was working better.Subsequently, his condition was impaired by functional renal failure.His creatinine and urea were increased dramatically and a generalized peripheral edema, starting on (b)(6), was noted.Under furosemide and global management of parenteral support, improvement of renal functions was noted on (b)(6), creatinine had dropped from 400 mmol/l to 200 mmol/l and urea from 31.6 mmol/l to 19.8 mmol/l.However, diuresis remains poor with urine output reduced to less than 50 cc/hour.His general condition slowly improved to fair with improved neurological status (gcs 8+t/15).The renal functions recovered gradually where on (b)(6), all biological parameter were in normal range as displayed in table 3; then the patient was transferred in general ward for continuation of physiotherapy and general surveillance.The patient was discharged on (b)(6) 2014 and transferred to (b)(6) district hospital, closer to his home village where he has continued physiotherapy, finally he joined his own home on (b)(6) 2014 where (b)(6) team visited him on (b)(6) 2014, he was found in very good condition.Discussion the present case report describes one case of tetanus developed during the healing period from vmmc.The patient is a farmer dealing with domestic animals and soil in his everyday life and his work exposes him to tetanus.It could be very difficult to determine the exact time of contamination because tetanus can have a long incubation period.There is also a tradition in (b)(6) to apply traditional medicines on wounds, and we are not sure if the patient had used traditional medications.Any opened wound or injury is subject to infection, including tetanus, if the client has been in contact with the germ.The key question is: where was the possible contact made, and how? the current patient history reveals that he was not immunized against tetanus and this could be also a risk factor.We are not sure if the patient was not infected before because the symptoms may start after wound healing or following a simple puncture, and the patient had cracks on his foot before the procedure.This infection seems not linked to the health facility (instrument sterilization or procedure), because after a 2-months follow-up of all cases, no other case has been reported.Risks factors for tetanus are many and include the following: lack of immunization or inadequate immunization[?]failure to receive timely booster shots[?]against tetanus.A penetrating injury that results in tetanus spores being introduced into the wound site.A surgical wound; the presence of other infective bacteria; injured tissue; a foreign body, such as a nail or splinter; swelling around the injury.(b)(6) and al.Reported 119 cases out of 1,839 hospitalized patients in the infectious disease department of point (b)(6) hospital.(b)(6)? and al.Reported 54 cases, of which 39% were acquired at home, 35% in health centers and 29% in unknown places.In (b)(6), tetanus has almost been eradicated in newborns and most of the programs are focused on pregnant women, newborns, and children.(8,9,10) most tetanus cases in adults reported in hospitals in (b)(6) are related to road traffic accidents or other injuries.In 2009, (b)(6) and al.Reported a case series of four patients treated in the icu of (b)(6) hospital.Two occurred in adults after injuries[?]one case involved a motorbike accident, the second was a peasant who injured his left hand with a machete while working in his field.The two cases in newborns occurred after delivery at home, when the babies' umbilical cords were cut off with non-sterilized instruments (6).In the 14 months that the icu of (b)(6) military hospital has been operating, 5 cases of tetanus have been already admitted to the unit.According to data from immunization department, from 2004 to 2013, over 12 cases of neonatal tetanus have been recorded among the only 3 survived.According to recent (b)(6) data, the coverage of immunization of pregnant women against tetanus 2 doses is 98% in 2013 while it was at 51% in 2004 and the coverage of dtp-hepb/hib3 for children under 11 months is 100% while it was 89% in 2004.This case report is as an alert to advocate for periodical tetanus immunization campaigns for adults in (b)(6) to ensure protection of the community, especially in rural areas, (11) as recommended by the immunization practices advisory committee of the centers for disease control, a primary immunisation program, should be followed by booster shots every 10 years (13 ).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.
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Event Description
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A (b)(6) year-old man, farmer living in a rural area in (b)(6) has been received at (b)(6) district hospital on (b)(6) 2014, at 4:00 p.M., complaining of muscle spasms localized in his back, face, upper limbs and lower limbs.Tetanus immediately came to the top of the list of differential diagnoses.Upon further history, the patient reported that he had not received tetanus immunization in the past.On (b)(6) 2014, the patient had presented to a voluntary medical male circumcision (vmmc) clinic that uses the prepex¿ device to undergo circumcision.When he arrived at the clinic, he was offered (b)(6) testing and tested (b)(6).Following the prepex-based male circumcision protocol, he was screened and found no contraindication for circumcision by prepex and was offered the service the same day, (b)(6).The client was given post-placement instruction, translated in the local language, on how to care for the wound and was also advised to return for removal of the dead foreskin to complete the service.Prepex removal was done on (b)(6) 2014.The service was provided during the vmmc campaign in (b)(6) health centre that aimed to circumcise 3,000 men in 4 weeks.(b)(6) health center is a clean, well-kept facility equipped with functional sterilization equipment that is used to sterilize all instruments for circumcision purposes.The placement and the removal of the prepex were performed by trained and certified health care providers and the procedures were performed under standardized aseptic conditions.Upon diagnosis of tetanus at (b)(6) hospital on (b)(6) 2014, the client was given procaine penicillin: 2 million ui/im; ceftriaxone: 1 gm; and metronidazole (flagyl): 500 mg.A peripheral intravenous line was opened and he was given 1,000 ml of ringer's lactate, 1,000 ml of normal saline and 500 ml of 10% glucose solution.Finally, he was given 3,000 ui/im of human serum tetanus immunoglobulin.The clinicians then decided to transfer the patient to (b)(6) hospital for better care, as the facility is equipped with an intensive care unit (icu) and staffed with highly trained anesthesiologists and other clinicians.On his arrival at (b)(6) on (b)(6), a physical examination revealed a patient with spasmic contractions, generalized body weakness between contractions, but fully alert and conscious, with a reading of 15/15 on the glasgow coma scale (gcs).He was hemodynamically stable with audible heart sounds but with tachycardia, blood pressure of 120/75 mmhg, heart rate 150 beats per minute, and strong palpable central and peripheral pulses.On clinical examination, he had good chest movement with sufficient/clear air entry to both lungs except for mild rhonchi in the left lung field.Oxygen saturation was 97% and his respiratory rate was 18 per minute.With the clinical diagnosis of tetanus, the care team at the military hospital also wanted to rule out the possibility of other infectious and non-infectious origins, e.G., meningitis or drug-induced spasms.Again, a thorough head-to-toe examination to identify possible tetanus spores entry was done; there were visible cracks on his feet, a clean circumcision wound, and scars on his neck and back from traditional healers who suspected meningitis.The (b)(6) team visited the patient's home.The patient lives in a typical (b)(6) rural farming home, with cattle in the compound and crops drying all around the compound.He is growing rice in a nearby swamp.After the prepex placement and removal, he continued his activities including moving around the shelter, giving mixed herbs to the cows and visiting his rice plantation.All seven of his children are immunized.The status of the mother's tetanus immunization is certain, as her youngest child is 5 years old.The patient was not immunized against tetanus.His 18-year-old son has been circumcised in the same period using prepex and he healed well.The care team decided on the following management: wound care: the wound was regularly cleaned with hydrogen peroxide twice a day and kept open.There was no necrotic tissue that needed to be removed.Medications: he received human immunoglobulin and tetanus vaccine on (b)(6) 2014; ampicillin iv 1 gm iv tid; and metronidazole iv 500 mg tid.He was also given sedatives: midazolam 6 mg per hour, which was later increased to 10 mg per hour; thiopental iv 50 to 75 mg prn; and pancuronium iv 4 mg every 3 hours.Given the increasing spasms on the upper body with trismus and the sedatives and muscle relaxants, the care team performed a tracheostomy, intubated the patient and provided mechanical ventilation using a respirator.Typical for tetanus, the signs[?]spasm and trismus[?]worsened with stimulus such as light and noise, so the client was kept in a dark and quiet room.After 3 days of care, however, on (b)(6), the patient developed a fever of 39 °c and his blood pressure started to drop; however, his other vital signs remained within the normal range the care team sent urine, blood and meningeal fluid samples to investigate the source of fever, (septic shock, malaria, and meningitis), and a swab sample was taken from the circumcision wound.The wound swab showed staphylococcus aureus.Liver and renal function tests were done, renal tests slightly elevated at admission were then within normal range, and liver tests (sgot, sgpt) both elevated.The care team pursued to investigate the reasons for the elevated liver function test.The tracheostomy site was clean and well-functioning.With a probable diagnosis of septic shock, additional antibiotics were added: on (b)(6) cefotaxime was initiated.On (b)(6), the patient's fever came down to 38 °c and his vital signs became stabilized.A try of oral feeding through a nasogastric tube on (b)(6) has not been well-tolerated and the patient was maintained on parenteral support; his temperature stayed around 38 °c.Without a clear explanation of persistent fever, a new full septic screening was rolled out on of june 16.Finally, a swab sample from tracheostomy wound revealed a klebsiella sensitive to imipenem; other samples were negatives.A combination of imipenem and metronidazole was started immediately.On (b)(6), it had been 36 hours since convulsions were observed, so a decision was made to hold off on all sedative medications.The patient presented with muscle rigidity, which could be addressed by regular physiotherapy, and he breathed spontaneously on continuous positive airway pressure mode.Meanwhile, enteral nutrition through the nasogastric tube was working better.Subsequently, his condition was impaired by functional renal failure.His creatinine and urea were increased dramatically and a generalized peripheral edema, starting on (b)(6), was noted.Under furosemide and global management of parenteral support, improvement of renal functions was noted on (b)(6), creatinine had dropped from 400 mmol/l to 200 mmol/l and urea from 31.6 mmol/l to 19.8 mmol/l.However, diuresis remains poor with urine output reduced to less than 50 cc/hour.His general condition slowly improved to fair with improved neurological status (gcs 8+t/15).The renal functions recovered gradually where on (b)(6), all biological parameter were in normal range as displayed in table 3; then the patient was transferred in general ward for continuation of physiotherapy and general surveillance.The patient was discharged on (b)(6) 2014 and transferred to (b)(6) district hospital, closer to his home village where he has continued physiotherapy, finally he joined his own home on (b)(6) 2014 where (b)(6) team visited him on (b)(6) 2014, he was found in very good condition.
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Manufacturer Narrative
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The following report was received from (b)(6): introduction: the present case reports describes a two months follow-up for a case of generalized tetanus that occurred during the healing period of a circumcised client successfully managed by clinicians in (b)(6).The purpose of this report is to describe the case and its probable association with a post-circumcision wound or any other lesions and provide recommendations on preventive measures to avoid similar cases case report: the patient permission for print and electronic publication was obtained before reporting.A (b)(6) man, farmer living in a rural area in (b)(6) has been received at (b)(6) on (b)(6) 2014, at 4:00 p.M., complaining of muscle spasms localized in his back, face, upper limbs and lower limbs.Tetanus immediately came to the top of the list of differential diagnoses.Upon further history, the patient reported that he had not received tetanus immunization in the past.On (b)(6) 2014, the patient had presented to a voluntary medical male circumcision (vmmc) clinic that uses the prepex¿ device to undergo circumcision.When he arrived at the clinic, he was offered (b)(6) testing and tested (b)(6).Following the prepex-based male circumcision protocol, he was screened and found no contraindication for circumcision by prepex and was offered the service the same day, (b)(6).The client was given post-placement instruction, translated in the local language, on how to care for the wound and was also advised to return for removal of the dead foreskin to complete the service.Prepex removal was done on (b)(6) 2014.The service was provided during the vmmc campaign in (b)(6) that aimed to circumcise 3,000 men in 4 weeks.(b)(6) is a clean, well-kept facility equipped with functional sterilization equipment that is used to sterilize all instruments for circumcision purposes.The placement and the removal of the prepex were performed by trained and certified health care providers and the procedures were performed under standardized aseptic conditions.Upon diagnosis of tetanus at (b)(6) on (b)(6) 2014, the client was given procaine penicillin: 2 million ui/im; ceftriaxone: 1 gm; and metronidazole (flagyl): 500 mg.A peripheral intravenous line was opened and he was given 1,000 ml of ringer's lactate, 1,000 ml of normal saline and 500 ml of 10% glucose solution.Finally, he was given 3,000 ui/im of human serum tetanus immunoglobulin.The clinicians then decided to transfer the patient to (b)(6) for better care, as the facility is equipped with an intensive care unit (icu) and staffed with highly trained anesthesiologists and other clinicians.On his arrival at (b)(6) on (b)(6), a physical examination revealed a patient with spasmic contractions, generalized body weakness between contractions, but fully alert and conscious, with a reading of 15/15 on the glasgow coma scale (gcs).He was hemodynamically stable with audible heart sounds but with tachycardia, blood pressure of 120/75 mmhg, heart rate 150 beats per minute, and strong palpable central and peripheral pulses.On clinical examination, he had good chest movement with sufficient/clear air entry to both lungs except for mild rhonchi in the left lung field.Oxygen saturation was 97% and his respiratory rate was 18 per minute.With the clinical diagnosis of tetanus, the care team at (b)(6) also wanted to rule out the possibility of other infectious and non-infectious origins, e.G., meningitis or drug-induced spasms.Again, a thorough head-to-toe examination to identify possible tetanus spores entry was done; there were visible cracks on his feet, a clean circumcision wound, and scars on his neck and back from traditional healers who suspected meningitis.A crack on left foot of the patient.The (b)(6) visited the patient's home.The patient lives in a typical (b)(6) rural farming home, with cattle in the compound and crops drying all around the compound.He is growing rice in a nearby swamp.After the prepex placement and removal, he continued his activities including moving around the shelter, giving mixed herbs to the cows and visiting his rice plantation.All seven of his children are immunized.The status of the mother's tetanus immunization is certain, as her youngest child is (b)(6).The patient was not immunized against tetanus.His (b)(6) son has been circumcised in the same period using prepex and he healed well.The care team decided on the following management: wound care: the wound was regularly cleaned with hydrogen peroxide twice a day and kept open.There was no necrotic tissue that needed to be removed.Medications: he received human immunoglobulin and tetanus vaccine on (b)(6) 2014; ampicillin iv 1 gm iv tid; and metronidazole iv 500 mg tid.He was also given sedatives: midazolam 6 mg per hour, which was later increased to 10 mg per hour; thiopental iv 50 to 75 mg prn; and pancuronium iv 4 mg every 3 hours.Given the increasing spasms on the upper body with trismus and the sedatives and muscle relaxants, the care team performed a tracheostomy, intubated the patient and provided mechanical ventilation using a respirator.Typical for tetanus, the signs[?]spasm and trismus[?]worsened with stimulus such as light and noise, so the client was kept in a dark and quiet room.After 3 days of care, however, on (b)(6), the patient developed a fever of 39 °c and his blood pressure started to drop; however, his other vital signs remained within the normal range the care team sent urine, blood and meningeal fluid samples to investigate the source of fever, (septic shock, malaria, and meningitis), and a swab sample was taken from the circumcision wound.The wound swab showed staphylococcus aureus.Liver and renal function tests were done, renal tests slightly elevated at admission were then within normal range, and liver tests (sgot, sgpt) both elevated.The care team pursued to investigate the reasons for the elevated liver function test.The tracheostomy site was clean and well-functioning.With a probable diagnosis of septic shock, additional antibiotics were added: on (b)(6), cefotaxime was initiated.On (b)(6), the patient's fever came down to 38 °c and his vital signs became stabilized.A try of oral feeding through a nasogastric tube on (b)(6) has not been well-tolerated and the patient was maintained on parenteral support; his temperature stayed around 38 °c.Without a clear explanation of persistent fever, a new full septic screening was rolled out on of (b)(6).Finally, a swab sample from tracheostomy wound revealed a klebsiella sensitive to imipenem; other samples were negatives.A combination of imipenem and metronidazole was started immediately.On (b)(6), it had been 36 hours since convulsions were observed, so a decision was made to hold off on all sedative medications.The patient presented with muscle rigidity, which could be addressed by regular physiotherapy, and he breathed spontaneously on continuous positive airway pressure mode.Meanwhile, enteral nutrition through the nasogastric tube was working better.Subsequently, his condition was impaired by functional renal failure.His creatinine and urea were increased dramatically and a generalized peripheral edema, starting on (b)(6), was noted.Under furosemide and global management of parenteral support, improvement of renal functions was noted on (b)(6), creatinine had dropped from 400 mmol/l to 200 mmol/l and urea from 31.6 mmol/l to 19.8 mmol/l.However, diuresis remains poor with urine output reduced to less than 50 cc/hour.His general condition slowly improved to fair with improved neurological status (gcs 8+t/15).The renal functions recovered gradually where on (b)(6) all biological parameter were in normal range as displayed in table 3; then the patient was transferred in general ward for continuation of physiotherapy and general surveillance.The patient was discharged on (b)(6) 2014 and transferred to (b)(6), closer to his home village where he has continued physiotherapy, finally he joined his own home on (b)(6) 2014 where (b)(6) visited him on (b)(6) 2014, he was found in very good condition.Discussion: the present case report describes one case of tetanus developed during the healing period from vmmc.The patient is a farmer dealing with domestic animals and soil in his everyday life and his work exposes him to tetanus.It could be very difficult to determine the exact time of contamination because tetanus can have a long incubation period.There is also a tradition in (b)(6) to apply traditional medicines on wounds, and we are not sure if the patient had used traditional medications.Any opened wound or injury is subject to infection, including tetanus, if the client has been in contact with the germ.The key question is: where was the possible contact made, and how.The current patient history reveals that he was not immunized against tetanus and this could be also a risk factor.We are not sure if the patient was not infected before because the symptoms may start after wound healing or following a simple puncture, and the patient had cracks on his foot before the procedure.This infection seems not linked to the health facility (instrument sterilization or procedure), because after a 2-months follow-up of all cases, no other case has been reported.Risks factors for tetanus are many and include the following: · lack of immunization or inadequate immunization[?]failure to receive timely booster shots[?]against tetanus.· a penetrating injury that results in tetanus spores being introduced into the wound site.· a surgical wound.· the presence of other infective bacteria.· injured tissue.· a foreign body, such as a nail or splinter.· swelling around the injury.Minta and al.Reported 119 cases out of 1,839 hospitalized patients in (b)(6).In (b)(6), soumar? and al.Reported 54 cases, of which 39% were acquired at home, 35% in health centers and 29% in unknown places.In (b)(6), tetanus has almost been eradicated in newborns and most of the programs are focused on pregnant women, newborns, and children.Most tetanus cases in adults reported in hospitals in (b)(6) are related to road traffic accidents or other injuries.In 2009, gibson and al.Reported a case series of four patients treated in the icu of (b)(6).Two occurred in adults after injuries[?]one case involved a motorbike accident, the second was a peasant who injured his left hand with a machete while working in his field.The two cases in newborns occurred after delivery at home, when the babies' umbilical cords were cut off with non-sterilized instruments.In the 14 months that the icu of (b)(6) has been operating, 5 cases of tetanus have been already admitted to the unit.According to data from immunization department, from 2004 to 2013, over 12 cases of neonatal tetanus have been recorded among the only 3 survived.According to recent hmis data, the coverage of immunization of pregnant women against tetanus 2 doses is 98% in 2013 while it was at 51% in 2004 and the coverage of dtp-hepb/hib3 for children under 11 months is 100% while it was 89% in 2004.This case report is as an alert to advocate for periodical tetanus immunization campaigns for adults in (b)(6) to ensure protection of the community, especially in rural areas, as recommended by the immunization practices advisory committee of the centers for disease control, a primary immunisation program, should be followed by booster shots every 10 years.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.
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Event Description
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A (b)(6) man, farmer living in a rural area in (b)(6) has been received at (b)(6) on (b)(6) 2014, at 4:00 p.M., complaining of muscle spasms localized in his back, face, upper limbs and lower limbs.Tetanus immediately came to the top of the list of differential diagnoses.Upon further history, the patient reported that he had not received tetanus immunization in the past.On (b)(6) 2014, the patient had presented to a voluntary medical male circumcision (vmmc) clinic that uses the prepex¿ device to undergo circumcision.When he arrived at the clinic, he was offered (b)(6) testing and tested (b)(6).Following the prepex-based male circumcision protocol, he was screened and found no contraindication for circumcision by prepex and was offered the service the same day, (b)(6).The client was given post-placement instruction, translated in the local language, on how to care for the wound and was also advised to return for removal of the dead foreskin to complete the service.Prepex removal was done on (b)(6) 2014.The service was provided during the vmmc campaign in (b)(6) that aimed to circumcise 3,000 men in 4 weeks.(b)(6) is a clean, well-kept facility equipped with functional sterilization equipment that is used to sterilize all instruments for circumcision purposes.The placement and the removal of the prepex were performed by trained and certified health care providers and the procedures were performed under standardized aseptic conditions.Upon diagnosis of tetanus at (b)(6) on (b)(6) 2014, the client was given procaine penicillin: 2 million ui/im; ceftriaxone: 1 gm; and metronidazole (flagyl): 500 mg.A peripheral intravenous line was opened and he was given 1,000 ml of ringer's lactate, 1,000 ml of normal saline and 500 ml of 10% glucose solution.Finally, he was given 3,000 ui/im of human serum tetanus immunoglobulin.The clinicians then decided to transfer the patient to (b)(6) for better care, as the facility is equipped with an intensive care unit (icu) and staffed with highly trained anesthesiologists and other clinicians.On his arrival at (b)(6) on (b)(6), a physical examination revealed a patient with spasmic contractions, generalized body weakness between contractions, but fully alert and conscious, with a reading of 15/15 on the glasgow coma scale (gcs).He was hemodynamically stable with audible heart sounds but with tachycardia, blood pressure of 120/75 mmhg, heart rate 150 beats per minute, and strong palpable central and peripheral pulses.On clinical examination, he had good chest movement with sufficient/clear air entry to both lungs except for mild rhonchi in the left lung field.Oxygen saturation was 97% and his respiratory rate was 18 per minute.With the clinical diagnosis of tetanus, the care team at (b)(6) also wanted to rule out the possibility of other infectious and non-infectious origins, e.G., meningitis or drug-induced spasms.Again, a thorough head-to-toe examination to identify possible tetanus spores entry was done; there were visible cracks on his feet, a clean circumcision wound, and scars on his neck and back from traditional healers who suspected meningitis.The (b)(6) visited the patient's home.The patient lives in a typical (b)(6) rural farming home, with cattle in the compound and crops drying all around the compound.He is growing rice in a nearby swamp.After the prepex placement and removal, he continued his activities including moving around the shelter, giving mixed herbs to the cows and visiting his rice plantation.All seven of his children are immunized.The status of the mother's tetanus immunization is certain, as her youngest child is (b)(6).The patient was not immunized against tetanus.His (b)(6) son has been circumcised in the same period using prepex and he healed well.The care team decided on the following management: wound care: the wound was regularly cleaned with hydrogen peroxide twice a day and kept open.There was no necrotic tissue that needed to be removed.Medications: he received human immunoglobulin and tetanus vaccine on (b)(6) 2014; ampicillin iv 1 gm iv tid; and metronidazole iv 500 mg tid.He was also given sedatives: midazolam 6 mg per hour, which was later increased to 10 mg per hour; thiopental iv 50 to 75 mg prn; and pancuronium iv 4 mg every 3 hours.Given the increasing spasms on the upper body with trismus and the sedatives and muscle relaxants, the care team performed a tracheostomy, intubated the patient and provided mechanical ventilation using a respirator.Typical for tetanus, the signs[?]spasm and trismus[?]worsened with stimulus such as light and noise, so the client was kept in a dark and quiet room.After 3 days of care, however, on (b)(6), the patient developed a fever of 39 °c and his blood pressure started to drop; however, his other vital signs remained within the normal range the care team sent urine, blood and meningeal fluid samples to investigate the source of fever, (septic shock, malaria, and meningitis), and a swab sample was taken from the circumcision wound.The wound swab showed staphylococcus aureus.Liver and renal function tests were done, renal tests slightly elevated at admission were then within normal range, and liver tests (sgot, sgpt) both elevated.The care team pursued to investigate the reasons for the elevated liver function test.The tracheostomy site was clean and well-functioning.With a probable diagnosis of septic shock, additional antibiotics were added: on (b)(6), cefotaxime was initiated.On (b)(6), the patient's fever came down to 38 °c and his vital signs became stabilized.A try of oral feeding through a nasogastric tube on (b)(6) has not been well-tolerated and the patient was maintained on parenteral support; his temperature stayed around 38 °c.Without a clear explanation of persistent fever, a new full septic screening was rolled out on of (b)(6).Finally, a swab sample from tracheostomy wound revealed a klebsiella sensitive to imipenem; other samples were negatives.A combination of imipenem and metronidazole was started immediately.On (b)(6), it had been 36 hours since convulsions were observed, so a decision was made to hold off on all sedative medications.The patient presented with muscle rigidity, which could be addressed by regular physiotherapy, and he breathed spontaneously on continuous positive airway pressure mode.Meanwhile, enteral nutrition through the nasogastric tube was working better.Subsequently, his condition was impaired by functional renal failure.His creatinine and urea were increased dramatically and a generalized peripheral edema, starting on (b)(6), was noted.Under furosemide and global management of parenteral support, improvement of renal functions was noted on (b)(6), creatinine had dropped from 400 mmol/l to 200 mmol/l and urea from 31.6 mmol/l to 19.8 mmol/l.However, diuresis remains poor with urine output reduced to less than 50 cc/hour.His general condition slowly improved to fair with improved neurological status (gcs 8+t/15).The renal functions recovered gradually where on (b)(6) all biological parameter were in normal range as displayed in table 3; then the patient was transferred in general ward for continuation of physiotherapy and general surveillance.The patient was discharged on (b)(6) 2014 and transferred to (b)(6), closer to his home village where he has continued physiotherapy, finally he joined his own home on (b)(6) 2014 where (b)(6) visited him on (b)(6) 2014, he was found in very good condition.
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