| Device Problem
Patient-Device Incompatibility (2682)
|
| Patient Problem
Toxic Shock Syndrome (2108)
|
| Event Date 02/02/2020 |
|
Event Type
Injury
|
|
Event Description
|
|
A (b)(6) year old female consumer reported that she was a long time user of playtex tampons and was 14-15 years old at the onset of menses.The consumer denied preexisting medical conditions and was not taking any medications at the time of the event.Consumer stated that she was seven months post delivery of her second child and breast fed for three months.She reported that this was not her first menses since giving birth.She reported that the tampon was left inside of her for no more than four hours.(b)(6) 2020, she felt sick with flu-like symptoms, could not get out of bed for a day or two, felt dizzy and could not eat.On (b)(6) 2020 she went to the emergency room and was admitted to the hospital.She reported that her heart rate was 142, blood pressure was 70/40 and she was in the intensive care unit for two days.She was diagnosed with toxic shock syndrome and treated with intravenous therapy meropenem, vancomycin and clindamyacin.Additional treatment medications included enoxaparin, zopiclone, acetaminophen and ondansetron.She was discharged from the hospital on (b)(6) 2020 with amoxicillin for 5 days.She saw her family doctor and gynecologist and her pap test results were normal.Consumer reported that she feels well but continues to experience dizziness from time to time.No additional follow up was required.The consumer discarded the product and packaging.The specific playtex tampon was not identified.
|
| |
|
Event Description
|
|
A 28 year old female consumer reported that she was a long time user of playtex tampons and was 14-15 years old at the onset of menses.The consumer denied preexisting medical conditions and was not taking any medications at the time of the event.Consumer stated that she was seven months post delivery of her second child and breast fed for three months.She reported that this was not her first menses since giving birth.She reported that the tampon was left inside of her for no more than four hours.(b)(6) 2020, she felt sick with flu-like symptoms, could not get out of bed for a day or two, felt dizzy and could not eat.On (b)(6) 2020 she went to the emergency room and was admitted to the hospital.She reported that her heart rate was 142, blood pressure was 70/40 and she was in the intensive care unit for two days.She was diagnosed with toxic shock syndrome and treated with intravenous therapy meropenem, vancomycin and clindamyacin.Additional treatment medications included enoxaparin, zopiclone, acetaminophen and ondansetron.She was discharged from the hospital on (b)(6) 2020 with amoxicillin for 5 days.She saw her family doctor and gynecologist and her pap test results were normal.Consumer reported that she feels well but continues to experience dizziness from time to time.No additional follow up was required.The consumer discarded the product and packaging.The specific playtex tampon was not identified.Updated suspect medical device to playtex sport tampon multipack unknown based on information from the consumer.Additional information received from the consumer on 08-apr-2020 included: upon admission to the hospital the consumer had an ultrasound and ct scan, no results were provided.Consumer stated that throughout her hospital stay she was hypotensive with systolic blood pressures in the 70s and 80s and diastolic blood pressures in the 40s.She was admitted to the intensive care unit with septic shock and experienced foul discharge.She stated that her hands, legs and feet were very swollen and her right hand was very sore, with her fingers feeling as though they were going to fall off because she lost a lot of feeling in her right hand and it would feel numb.Consumer stated that since being discharged from the hospital she had her menstrual cycle and did not use tampons.
|
| |
|
Manufacturer Narrative
|
|
The investigations found no correlation or association between the manufacturing of the sport super product at edgewell's dover, delaware plant and the reported tss event.No trends were identified between the tss event in question and other consumer complaints.No product design or risk assessment concerns were identified.No nonconformances or out of specification test results were present in the device history records.No change control, trial or validation concerns were identified.No material supplier changes could be linked with the tss event.No manufacturing record concerns were identified.No data was present in the calibration records to indicate syngyna absorbency testing failure.No out of specification results were present for raw material receiving inspection or environmental monitoring.No equipment cleanliness or environmental deficiencies could be associated with the tss event were identified.The investigation results confirmed that the product met specifications.All quality systems including device design, instructions for use, packaging, and labeling, supplier data, manufacturing data and test results were functioning as intended.The investigation found no evidence to support an association with the reported tss event.No effectiveness verification is required as the investigation did not find an association between the manufacturing of the product and the reported tss event.The investigation did not find any association between the manufacturing of the product and the reported tss event, therefore no corrective action was required.
|
| |
|
Event Description
|
|
A 28 year old female consumer reported that she was a long time user of playtex tampons and was 14-15 years old at the onset of menses.The consumer denied preexisting medical conditions and was not taking any medications at the time of the event.Consumer stated that she was seven months post delivery of her second child and breast fed for three months.She reported that this was not her first menses since giving birth.She reported that the tampon was left inside of her for no more than four hours.(b)(6) 2020, she felt sick with flu-like symptoms, could not get out of bed for a day or two, felt dizzy and could not eat.On (b)(6) 2020 she went to the emergency room and was admitted to the hospital.She reported that her heart rate was 142, blood pressure was 70/40 and she was in the intensive care unit for two days.She was diagnosed with toxic shock syndrome and treated with intravenous therapy meropenem, vancomycin and "clindamycin".Additional treatment medications included enoxaparin, zopiclone, acetaminophen and ondansetron.She was discharged from the hospital on (b)(6) 2020 with amoxicillin for 5 days.She saw her family doctor and gynecologist and her pap test results were normal.Consumer reported that she feels well but continues to experience dizziness from time to time.No additional follow up was required.The consumer discarded the product and packaging.The specific playtex tampon was not identified.Updated suspect medical device to playtex sport tampon multipack unknown based on information from the consumer.Additional information received from the consumer on 08-apr-2020 included: upon admission to the hospital the consumer had an ultrasound and ct scan, no results were provided.Consumer stated that throughout her hospital stay she was hypotensive with systolic blood pressures in the 70s and 80s and diastolic blood pressures in the 40s.She was admitted to the intensive care unit with septic shock and experienced foul discharge.She stated that her hands, legs and feet were very swollen and her right hand was very sore, with her fingers feeling as though they were going to fall off because she lost a lot of feeling in her right hand and it would feel numb.Consumer stated that since being discharged from the hospital she had her menstrual cycle and did not use tampons.Additional information received from the consumer on 20-apr-2020: as per the hospital discharge summary provided by the consumer as she was reluctant to provide consent for the medical facility to be contacted.The consumer was admitted to the hospital on (b)(6) 2020 complaining of feeling sick since (b)(6) 2020 and was febrile with temperature of 39-40 degrees.She complained of dysuria as well as some loose bowels.She denied any nausea or vomiting, no chest pain, no shortness of breath and no cough.She recently finished her menstrual cycle on (b)(6) 2020 and reported that when she removed the tampon she noticed a large amount of foul smelling discharge (tampon was in for 5 hours).Vital signs included temperature up to 38.1 degrees.She was hypotensive throughout her stay, heart rate 112, saturating 99% on room air.Labs included: leukocyte count 21.4, hemoglobin 144, platelets 263, lactate 3.6, coming down to 1.9.Creatinine 107.Her baseline was 54.Creatinine kinase 240 and sodium 131.Urinalysis was positive for leukocytes and bacteria.Kub was normal and chest x-ray was unremarkable.Computed tomography scan (ct) of abdomen showed no definite abscess with haziness in the region of the uterus and vagina which may indicate inflammation.Nasopharyngeal swab (np) swab on (b)(6) 2020 was negative.Blood cultures on (b)(6) 2020 showed no growth after 5 days.Echocardiogram was essentially normal ejection fraction was 68% no masses or vegetation seen.Speculum exam showed purulent material in the vagina.Cultures were taken from the cervix for gonorrhea and chlamydia, unfortunately, the swabs were taken in the wrong medium so were not processed.It was felt that with history of tampon use and purulent discharge, this could be staphylococcal toxic shock syndrome.Most responsible diagnosis was listed as toxic shock syndrome secondary to tampon.
|
| |
|
Manufacturer Narrative
|
|
The investigations found no correlation or association between the manufacturing of the sport super product at edgewell's dover, delaware plant and the reported tss event.No trends were identified between the tss event in question and other consumer complaints.No product design or risk assessment concerns were identified.No nonconformances or out of specification test results were present in the device history records.No change control, trial or validation concerns were identified.No material supplier changes could be linked with the tss event.No manufacturing record concerns were identified.No data was present in the calibration records to indicate syngyna absorbency testing failure.No out of specification results were present for raw material receiving inspection or environmental monitoring.No equipment cleanliness or environmental deficiencies could be associated with the tss event were identified.The investigation results confirmed that the product met specifications.All quality systems including device design, instructions for use, packaging, and labeling, supplier data, manufacturing data and test results were functioning as intended.The investigation found no evidence to support an association with the reported tss event.No effectiveness verification is required as the investigation did not find an association between the manufacturing of the product and the reported tss event.The investigation did not find any association between the manufacturing of the product and the reported tss event, therefore no corrective action was required.
|
| |
|
Event Description
|
|
A 28 year old female consumer reported that she was a long time user of playtex tampons and was 14-15 years old at the onset of menses.The consumer denied preexisting medical conditions and was not taking any medications at the time of the event.Consumer stated that she was seven months post delivery of her second child and breast fed for three months.She reported that this was not her first menses since giving birth.She reported that the tampon was left inside of her for no more than four hours.(b)(6) 2020, she felt sick with flu-like symptoms, could not get out of bed for a day or two, felt dizzy and could not eat.On (b)(6) 2020 she went to the emergency room and was admitted to the hospital.She reported that her heart rate was 142, blood pressure was 70/40 and she was in the intensive care unit for two days.She was diagnosed with toxic shock syndrome and treated with intravenous therapy meropenem, vancomycin and clindamyacin.Additional treatment medications included enoxaparin, zopiclone, acetaminophen and ondansetron.She was discharged from the hospital on (b)(6) 2020 with amoxicillin for 5 days.She saw her family doctor and gynecologist and her pap test results were normal.Consumer reported that she feels well but continues to experience dizziness from time to time.No additional follow up was required.The consumer discarded the product and packaging.The specific playtex tampon was not identified.Updated suspect medical device to playtex sport tampon multipack unknown based on information from the consumer.Additional information received from the consumer on (b)(6) 2020 included: upon admission to the hospital the consumer had an ultrasound and ct scan, no results were provided.Consumer stated that throughout her hospital stay she was hypotensive with systolic blood pressures in the 70s and 80s and diastolic blood pressures in the 40s.She was admitted to the intensive care unit with septic shock and experienced foul discharge.She stated that her hands, legs and feet were very swollen and her right hand was very sore, with her fingers feeling as though they were going to fall off because she lost a lot of feeling in her right hand and it would feel numb.Consumer stated that since being discharged from the hospital she had her menstrual cycle and did not use tampons.Additional information received from the consumer on (b)(6) 2020: as per the hospital discharge summary provided by the consumer as she was reluctant to provide consent for the medical facility to be contacted.The consumer was admitted to the hospital on (b)(6) 2020 complaining of feeling sick since (b)(6) 2020 and was febrile with temperature of 39-40 degrees.She complained of dysuria as well as some loose bowels.She denied any nausea or vomiting, no chest pain, no shortness of breath and no cough.She recently finished her menstrual cycle on (b)(6) 2020 and reported that when she removed the tampon she noticed a large amount of foul smelling discharge (tampon was in for 5 hours).Vital signs included temperature up to 38.1 degrees.She was hypotensive throughout her stay, heart rate 112, saturating 99% on room air.Labs included: leukocyte count 21.4, hemoglobin 144, platelets 263, lactate 3.6, coming down to 1.9.Creatinine 107.Her baseline was 54.Creatinine kinase 240 and sodium 131.Urinalysis was positive for leukocytes and bacteria.Kub was normal and chest x-ray was unremarkable.Computed tomography scan (ct) of abdomen showed no definite abscess with haziness in the region of the uterus and vagina which may indicate inflammation.Nasopharyngeal swab (np) swab on (b)(6) 2020 was negative.Blood cultures on (b)(6) 2020 showed no growth after 5 days.Echocardiogram was essentially normal ejection fraction was 68% no masses or vegetation seen.Speculum exam showed purulent material in the vagina.Cultures were taken from the cervix for gonorrhea and chlamydia, unfortunately, the swabs were taken in the wrong medium so were not processed.It was felt that with history of tampon use and purulent discharge, this could be staphylococcal toxic shock syndrome.Most responsible diagnosis was listed as toxic shock syndrome secondary to tampon.Additional information from medical records received on (b)(6) 2020 included: a 28 year old female with no significant medical history and on no medications was admitted from the emergency room on (b)(6) 2020 complaining of feeling sick with fevers and erythematous rash over trunk and thighs.She developed a fever on (b)(6) 2020 and on admission was found to be febrile with temperature of 39-40 degrees.She complained of dysuria as well with some loose bowels.She denied any nausea or vomiting had no chest pain, no shortness of breath and no cough.She recently finished her menstrual cycle the day before admission and reported that when her tampon was removed, she noticed a large amount of foul smelling discharge, tampon was inserted for 5 hours.Vital signs: temperature up to 38.1 degrees in the hospital, but it was 39-40 degrees at home.Blood pressure had been hypotensive throughout her stay, being in the 70s to 80s systolic over 40s diastolic, heart rate 112, saturating 99% on room air.Leukocyte count 21.4, hemoglobin 144, platelets of 263, lactate was 3.6, coming down to 1.9.Creatinine 107, her baseline was 54, creatinine kinase 240 and sodium 131.Labs were drawn and an iv inserted with d5w/0.9% nacl 1000 ml/hr bolus and she was given zofran 4mg iv and advil 400 mg po.Urinalysis was positive for leukocytes and bacteria, kub was normal and chest x-ray was unremarkable.Consumer complained of her fingers becoming numb and swollen due to fluid overload.Numbness improved after fluids were discontinued.Bp was still low despite an additional 2 liter bolus of normal saline.A foley catheter was inserted with urine returned, vaginal exam was positive for discharge and consumer reported tenderness in vagina developed the day before.She was tender to touch on bilateral thighs and right-sided abdomen / flank.She had redness, tenderness and swelling of perineum.Pyelonephritis and possible tss were discussed.On (b)(6) 2020 she remained hypotensive, an abdominal ultrasound was done and she was transferred from the emergency department to the intensive care unit (icu) with sepsis and toxic shock syndrome (tss) for possible vasopressors and monitoring and started empirically broad-spectrum antibiotics which included meropenum, vancomycin and clindamycin.A ct scan of abdomen was done which showed no definite abscess identified, haziness in the region of the uterus and vagina which may indicate inflammation.Nasopharyngeal swab was negative.She was seen by gynecology and a speculum exam was performed which showed a lot of purulent material in the vagina.Cultures were taken from the cervix for gonorrhea and chlamydia, unfortunately the swabs were taken in the wrong medium so were not processed.It was felt that with history of the tampon and purulent discharge, this could be staphylococcal toxic shock syndrome.Pelvic inflammatory disease was low on differential as there was no findings on exam.She improved and was transferred to a medical unit on (b)(6) /2020.On (b)(6) 2020 she complained of neck pain which she felt was due to her sleeping position and was controlled with tylenol.She was more mobile and able to ambulate to the bathroom and had no other complaints of pain.She continued to do well and her antibiotics were slowly de-escalated and later step down to clavulin orally.Consumer was discharged on (b)(6) 2020.Discharge medications included amoxicillin/clavulanate potassium (clavulin 875/125 mg) 1 tab po bid for five days.Diagnosis was tss secondary to tampon.Follow up recommendations were to follow up with her family doctor in 5-7 days, if needed, follow up with her gynecologist in 4-6 weeks and to return to the er if severe chills or feeling unwell.Treatment medications included: tylenol (acetaminophen) 325-975 mg po q6h prn from (b)(6) 2020, tylenol (acetaminophen) 325 mg supp rectal q6h prn from (b)(6) 2020, advil (ibuprofen) 400mg po on (b)(6) 2020, nitrofurantoin macrocystals 100 mg (1 capsule) on (b)(6) 2020, amoxicillin/clavulin 875/125 mg, 1 tab po bid on (b)(6) 2020, clindamycin 900 mg (6 ml) q8h iv from (b)(6) 2020, dimenhydrinate 50mg (1 ml) iv q4h prn from (b)(6) 2020, magnesium sulfate 1 g (52ml iv) on (b)(6) 2020, chlorhexidine gluconate 15ml po bid from (b)(6) 2020, lovenox (enoxaparin) 40mg (0.4ml) sc qhs from (b)(6) 2020, meropenem 500mg iv q6h from (b)(6) 2020, morphine 2 mg iv, q10m prn from (b)(6) 2020, zofran (ondansetron) 4mg tab po q6h prn from (b)(6) 2020, zofran (ondansetron) 4mg, iv q6h prn from (b)(6) 2020, phosphate effervescent 1,0000 mg, 2 tabs po once on (b)(6) 2020, potassium chloride 40mmol (30 ml) on (b)(6) 2020, sodium phosphate 1000mg po on (b)(6) 2020, vancomycin 1000mg (20 ml) iv q12hour from (b)(6) 2020, vancomycin 500mg (10 ml) iv q6h from (b)(6) 2020, inovane (zopiclone) 7.5mg2 tabs po qhs from (b)(6) 2020, piperacillin/tazobactam 4.5g (23.15 ml) q6hr from (b)(6) 2020, rocephin (ceftriaxone) 1000mg iv on (b)(6) 2020 and gravol (dimenhydrate) 25mg iv q4h prn on (b)(6) 2020.
|
| |
|
Manufacturer Narrative
|
|
The investigations found no correlation or association between the manufacturing of the sport super product at edgewell's dover, delaware plant and the reported tss event.No trends were identified between the tss event in question and other consumer complaints.No product design or risk assessment concerns were identified.No nonconformances or out of specification test results were present in the device history records.No change control, trial or validation concerns were identified.No material supplier changes could be linked with the tss event.No manufacturing record concerns were identified.No data was present in the calibration records to indicate syngyna absorbency testing failure.No out of specification results were present for raw material receiving inspection or environmental monitoring.No equipment cleanliness or environmental deficiencies could be associated with the tss event were identified.The investigation results confirmed that the product met specifications.All quality systems including device design, instructions for use, packaging, and labeling, supplier data, manufacturing data and test results were functioning as intended.The investigation found no evidence to support an association with the reported tss event.No effectiveness verification is required as the investigation did not find an association between the manufacturing of the product and the reported tss event.The investigation did not find any association between the manufacturing of the product and the reported tss event, therefore no corrective action was required.
|
| |
|
Manufacturer Narrative
|
|
The investigations found no correlation or association between the manufacturing of the sport super product at edgewell's dover, delaware plant and the reported tss event.No trends were identified between the tss event in question and other consumer complaints.No product design or risk assessment concerns were identified.No nonconformances or out of specification test results were present in the device history records.No change control, trial or validation concerns were identified.No material supplier changes could be linked with the tss event.No manufacturing record concerns were identified.No data was present in the calibration records to indicate syngyna absorbency testing failure.No out of specification results were present for raw material receiving inspection or environmental monitoring.No equipment cleanliness or environmental deficiencies could be associated with the tss event were identified.The investigation results confirmed that the product met specifications.All quality systems including device design, instructions for use, packaging, and labeling, supplier data, manufacturing data and test results were functioning as intended.The investigation found no evidence to support an association with the reported tss event.No effectiveness verification is required as the investigation did not find an association between the manufacturing of the product and the reported tss event.The investigation did not find any association between the manufacturing of the product and the reported tss event, therefore no corrective action was required.
|
| |
|
Event Description
|
|
A 28 year old female consumer reported that she was a long time user of playtex tampons and was 14-15 years old at the onset of menses.The consumer denied preexisting medical conditions and was not taking any medications at the time of the event.Consumer stated that she was seven months post delivery of her second child and breast fed for three months.She reported that this was not her first menses since giving birth.She reported that the tampon was left inside of her for no more than four hours.(b)(6) 2020, she felt sick with flu-like symptoms, could not get out of bed for a day or two, felt dizzy and could not eat.On (b)(6) 2020 she went to the emergency room and was admitted to the hospital.She reported that her heart rate was 142, blood pressure was 70/40 and she was in the intensive care unit for two days.She was diagnosed with toxic shock syndrome and treated with intravenous therapy meropenem, vancomycin and clindamyacin.Additional treatment medications included enoxaparin, zopiclone, acetaminophen and ondansetron.She was discharged from the hospital on (b)(6) 2020 with amoxicillin for 5 days.She saw her family doctor and gynecologist and her pap test results were normal.Consumer reported that she feels well but continues to experience dizziness from time to time.No additional follow up was required.The consumer discarded the product and packaging.The specific playtex tampon was not identified.Updated suspect medical device to playtex sport tampon multipack unknown based on information from the consumer.Additional information received from the consumer on (b)(6) 2020 included: upon admission to the hospital the consumer had an ultrasound and ct scan, no results were provided.Consumer stated that throughout her hospital stay she was hypotensive with systolic blood pressures in the 70s and 80s and diastolic blood pressures in the 40s.She was admitted to the intensive care unit with septic shock and experienced foul discharge.She stated that her hands, legs and feet were very swollen and her right hand was very sore, with her fingers feeling as though they were going to fall off because she lost a lot of feeling in her right hand and it would feel numb.Consumer stated that since being discharged from the hospital she had her menstrual cycle and did not use tampons.Additional information received from the consumer on (b)(6) 2020: as per the hospital discharge summary provided by the consumer as she was reluctant to provide consent for the medical facility to be contacted.The consumer was admitted to the hospital on (b)(6) 2020 complaining of feeling sick since (b)(6) 2020 and was febrile with temperature of 39-40 degrees.She complained of dysuria as well as some loose bowels.She denied any nausea or vomiting, no chest pain, no shortness of breath and no cough.She recently finished her menstrual cycle on (b)(6) 2020 and reported that when she removed the tampon she noticed a large amount of foul smelling discharge (tampon was in for 5 hours).Vital signs included temperature up to 38.1 degrees.She was hypotensive throughout her stay, heart rate 112, saturating 99% on room air.Labs included: leukocyte count 21.4, hemoglobin 144, platelets 263, lactate 3.6, coming down to 1.9.Creatinine 107.Her baseline was 54.Creatinine kinase 240 and sodium 131.Urinalysis was positive for leukocytes and bacteria.Kub was normal and chest x-ray was unremarkable.Computed tomography scan (ct) of abdomen showed no definite abscess with haziness in the region of the uterus and vagina which may indicate inflammation.Nasopharyngeal swab (np) swab on (b)(6) 2020 was negative.Blood cultures on (b)(6) 2020 showed no growth after 5 days.Echocardiogram was essentially normal ejection fraction was 68% no masses or vegetation seen.Speculum exam showed purulent material in the vagina.Cultures were taken from the cervix for gonorrhea and chlamydia, unfortunately, the swabs were taken in the wrong medium so were not processed.It was felt that with history of tampon use and purulent discharge, this could be staphylococcal toxic shock syndrome.Most responsible diagnosis was listed as toxic shock syndrome secondary to tampon.Additional information from medical records received on (b)(6) 2020 included: a 28 year old female with no significant medical history and on no medications was admitted from the emergency room on (b)(6) 2020 complaining of feeling sick with fevers and erythematous rash over trunk and thighs.She developed a fever on (b)(6) 2020 and on admission was found to be febrile with temperature of 39-40 degrees.She complained of dysuria as well with some loose bowels.She denied any nausea or vomiting had no chest pain, no shortness of breath and no cough.She recently finished her menstrual cycle the day before admission and reported that when her tampon was removed, she noticed a large amount of foul smelling discharge, tampon was inserted for 5 hours.Vital signs: temperature up to 38.1 degrees in the hospital, but it was 39-40 degrees at home.Blood pressure had been hypotensive throughout her stay, being in the 70s to 80s systolic over 40s diastolic, heart rate 112, saturating 99% on room air.Leukocyte count 21.4, hemoglobin 144, platelets of 263, lactate was 3.6, coming down to 1.9.Creatinine 107, her baseline was 54, creatinine kinase 240 and sodium 131.Labs were drawn and an iv inserted with d5w/0.9% nacl 1000 ml/hr bolus and she was given zofran 4mg iv and advil 400 mg po.Urinalysis was positive for leukocytes and bacteria, kub was normal and chest x-ray was unremarkable.Consumer complained of her fingers becoming numb and swollen due to fluid overload.Numbness improved after fluids were discontinued.Bp was still low despite an additional 2 liter bolus of normal saline.A foley catheter was inserted with urine returned, vaginal exam was positive for discharge and consumer reported tenderness in vagina developed the day before.She was tender to touch on bilateral thighs and right-sided abdomen / flank.She had redness, tenderness and swelling of perineum.Pyelonephritis and possible tss were discussed.On (b)(6) 2020 she remained hypotensive, an abdominal ultrasound was done and she was transferred from the emergency department to the intensive care unit (icu) with sepsis and toxic shock syndrome (tss) for possible vasopressors and monitoring and started empirically broad-spectrum antibiotics which included meropenum, vancomycin and clindamycin.A ct scan of abdomen was done which showed no definite abscess identified, haziness in the region of the uterus and vagina which may indicate inflammation.Nasopharyngeal swab was negative.She was seen by gynecology and a speculum exam was performed which showed a lot of purulent material in the vagina.Cultures were taken from the cervix for gonorrhea and chlamydia, unfortunately the swabs were taken in the wrong medium so were not processed.It was felt that with history of the tampon and purulent discharge, this could be staphylococcal toxic shock syndrome.Pelvic inflammatory disease was low on differential as there was no findings on exam.She improved and was transferred to a medical unit on (b)(6) 2020.On (b)(6) 2020 she complained of neck pain which she felt was due to her sleeping position and was controlled with tylenol.She was more mobile and able to ambulate to the bathroom and had no other complaints of pain.She continued to do well and her antibiotics were slowly de-escalated and later step down to clavulin orally.Consumer was discharged on (b)(6) 2020.Discharge medications included amoxicillin/clavulanate potassium (clavulin 875/125 mg) 1 tab po bid for five days.Diagnosis was tss secondary to tampon.Follow up recommendations were to follow up with her family doctor in 5-7 days, if needed, follow up with her gynecologist in 4-6 weeks and to return to the er if severe chills or feeling unwell.Treatment medications included: tylenol (acetaminophen) 325-975 mg po q6h prn from (b)(6) 2020, tylenol (acetaminophen) 325 mg supp rectal q6h prn from (b)(6) 2020, advil (ibuprofen) 400mg po on (b)(6) 2020, nitrofurantoin macrocystals 100 mg (1 capsule) on (b)(6) 2020, amoxicillin/clavulin 875/125 mg, 1 tab po bid on (b)(6) 2020, clindamycin 900 mg (6 ml) q8h iv from (b)(6) 2020, dimenhydrinate 50mg (1 ml) iv q4h prn from (b)(6) 2020, magnesium sulfate 1 g (52ml iv) on (b)(6) 2020, chlorhexidine gluconate 15ml po bid from (b)(6) 2020, lovenox (enoxaparin) 40mg (0.4ml) sc qhs from (b)(6) 2020, meropenem 500mg iv q6h from (b)(6) 2020, morphine 2 mg iv, q10m prn from (b)(6) 2020, zofran (ondansetron) 4mg tab po q6h prn from (b)(6) 2020, zofran (ondansetron) 4mg, iv q6h prn from (b)(6) 2020, phosphate effervescent 1,0000 mg, 2 tabs po once on(b)(6) 2020, potassium chloride 40mmol (30 ml) on (b)(6) 2020, sodium phosphate 1000mg po on (b)(6) 2020, vancomycin 1000mg (20 ml) iv q12hour from (b)(6) 2020, vancomycin 500mg (10 ml) iv q6h from (b)(6) 2020, inovane (zopiclone) 7.5mg2 tabs po qhs from (b)(6) 2020, piperacillin/tazobactam 4.5g (23.15 ml) q6hr from (b)(6) 2020, rocephin (ceftriaxone) 1000mg iv on (b)(6) 2020 and gravol (dimenhydrate) 25mg iv q4h prn on (b)(6) 2020.This follow up report is being submitted to correct the date of this report and to add the delay comment.This follow up report was delayed due to technical issues with updating the webtrader software.
|
| |
|
Search Alerts/Recalls
|
|
