MAUDE Adverse Event Report: PLAYTEX MANUFACTURING INC. PLAYTEX SPORT TAMPONS, 36 CT SUPER UNSCENTED; TAMPON, MENSTRUAL, UNSCENTED

Lot Number 18206W

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 02/06/2019

Event Type  Injury  

Event Description

A female consumer reported that her daughter was a healthy, (b)(6), athlete who came down with toxic shock syndrome (tss) while using playtex sport tampons.She stated that her daughter started her menses in the seventh grade, had a heavy blood flow and always used super absorbency tampons.She stated that her daughter had slept overnight with the tampon and the tampon was probably inserted for 9-10 hours.On (b)(6) 2019 her daughter was not feeling well, had a fever of 102, symptoms of sweating, chills, body aches and lightheadedness.Advil and tylenol were taken for the symptoms.On (b)(6) 2019 she had a fever of 101.7, a backache, an itchy rash from head to toe and left sided weakness.She took her to the pediatrician's office where her blood pressure was 80/50 and heart rate was 120.The pediatrician advised her to take her daughter to the emergency room (er).In the er, blood and vaginal cultures were taken and intravenous therapy of antibiotics; clindamycin, vancomycin and ceftriaxone were started.She was transferred to another hospital's pediatric intensive care unit where norepinephrine was administered due to her low blood pressure and an arterial line was inserted.She was swollen with twenty pounds of fluid and had shortness of breath due to her lungs being filled with fluid.Oxygen was administered.She stated that her daughter started feeling better and her breathing had improved.She was discharged from the hospital on (b)(6) 2019 with keflex and clindamycin.She followed up with the doctor on (b)(6) 2019 and was back to school on (b)(6) 2019.The consumer stated that she discarded the remaining tampons (1/2 box).

Event Description

A female consumer reported that her daughter was a healthy, 16-year-old, athlete who came down with toxic shock syndrome (tss) while using playtex sport tampons.She stated that her daughter started her menses in the seventh grade, had a heavy blood flow and always used super absorbency tampons.She stated that her daughter had slept overnight with the tampon and the tampon was probably inserted for 9-10 hours.On (b)(6) 2019 her daughter was not feeling well, had a fever of 102, symptoms of sweating, chills, body aches and lightheadedness.Advil and tylenol were taken for the symptoms.On (b)(6) 2019 she had a fever of 101.7, a backache, an itchy rash from head to toe and left sided weakness.She took her to the pediatrician's office where her blood pressure was 80/50 and heart rate was 120.The pediatrician advised her to take her daughter to the emergency room (er).In the er, blood and vaginal cultures were taken and intravenous therapy of antibiotics; clindamycin, vancomycin and ceftriaxone were started.She was transferred to another hospital's pediatric intensive care unit where norepinephrine was administered due to her low blood pressure and an arterial line was inserted.She was swollen with twenty pounds of fluid and had shortness of breath due to her lungs being filled with fluid.Oxygen was administered.She stated that her daughter started feeling better and her breathing had improved.She was discharged from the hospital on (b)(6) 2019with keflex and clindamycin.She followed up with the doctor on (b)(6) 2019and was back to school on (b)(6) 2019.The consumer stated that she discarded the remaining tampons (1/2 box).Additional information received on (b)(6) 2019: as per the medical records from the second treating facility, the consumer was transferred and initially admitted to the pediatric intensive care unit (picu) for blood pressure support, fluid management and continuation of antibiotics.A vaginal culture was noted to be positive for methicillin-sensitive staph aureus (most likely what caused the infection) from tampon use.Given the etiology of tss and improvement while in the picu, fluids were discontinued and antibiotics were narrowed to cephalexin and clindamycin.Admitting diagnoses included tss, primary electrolyte abnormality, tachycardia, thrombocytopenia, fever, caogulopathy, acute kidney injury, tachypnea, acute pain and hypotension.Treatment medications included: acetaminophen (tylenol) 500 mg tablet po q4h prn for mild pain on (b)(6) 2019 and 650 mg po q4h prn for temperature above100.4 from 02/09/2019 to 02/10/2019, calcium gluconate as salt 50 mg/ml injection dilution 3,000 mg (48.2 mg/kg/dose) iv once on (b)(6) 2019, ceftriaxone (rocephin) 40 mg/ml injection dilution 2000 mg (32.1 mg/kg/dose) iv q24 h on (b)(6) 2019, cephalexin (keflex) capsule 500 mg (8.03 mg/kg/dose) po qid starting on (b)(6) 2019, clindamycin (cleocin) 18 mg/ml injection iv q8h from (b)(6) 2019 through (b)(6) 2019 and clindamycin capsule 450 mg po qid from (b)(6) 2019 through (b)(6) 2019, diphenhydramine (benadryl) 25 mg tablet po prn for itching starting on(b)(6) 2019and famotidine (pepcid) 4 mg/ml inj dilution 20 mg iv q12h starting on (b)(6) 2019, lactated ringers infusion 100 ml/hr iv, continuous starting on (b)(6) 2019, lidocaine-prilocaine (emla) 2.5-2.5 % topical cream once on (b)(6) 2019, magnesium sulfate 40 mg/ml rtu inj 2,000 mg (32.1 mg/kg/dose) iv once on (b)(6) 2019f, melatonin tablet 3 mg po, nightly prn, norepinephrine (levophed) 0.02 mg/ml in dextrose 5% in water infusion iv continuous starting on (b)(6) 2019, ondansetron (zofran) 4 mg/2ml inj iv q8h prn nausea, vomiting, pantoprazole (protonix) ec tablet 40 mg, po daily fist dose on (b)(6) 2019, phytonadione (vitamin k) 2 mg/ml iv once on (b)(6) 2019through (b)(6) 2019, sertraline (zoloft) tablet 50 mg po daily starting(b)(6) 2019, sodium chloride (ocean) 0.65 % nasal spray, 2 sprays each nare q 1h prn congestion starting on (b)(6) 2019, vancomycin (vancocin) 5 mg/ml inj dilution 935 mg iv q6h starting on (b)(6) 2019through (b)(6) 2019 discharge medications included: cephalexin 500 mg po qid for 9 days and clindamycin 450 mg po qid for 9 days, both starting on (b)(6) 2019through (b)(6) 2019.

Event Description

A female consumer reported that her daughter was a healthy, 16-year-old, athlete who came down with toxic shock syndrome (tss) while using playtex sport tampons.She stated that her daughter started her menses in the seventh grade, had a heavy blood flow and always used super absorbency tampons.She stated that her daughter had slept overnight with the tampon and the tampon was probably inserted for 9-10 hours.On (b)(6) 2019 her daughter was not feeling well, had a fever of 102, symptoms of sweating, chills, body aches and lightheadedness.Advil and tylenol were taken for the symptoms.On (b)(6) 2019 she had a fever of 101.7, a backache, an itchy rash from head to toe and left sided weakness.She took her to the pediatrician's office where her blood pressure was 80/50 and heart rate was 120.The pediatrician advised her to take her daughter to the emergency room (er).In the er, blood and vaginal cultures were taken and intravenous therapy of antibiotics; clindamycin, vancomycin and ceftriaxone were started.She was transferred to another hospital's pediatric intensive care unit where norepinephrine was administered due to her low blood pressure and an arterial line was inserted.She was swollen with twenty pounds of fluid and had shortness of breath due to her lungs being filled with fluid.Oxygen was administered.She stated that her daughter started feeling better and her breathing had improved.She was discharged from the hospital on (b)(6) 2019 with keflex and clindamycin.She followed up with the doctor on (b)(6) 2019 and was back to school on (b)(6) 2019.The consumer stated that she discarded the remaining tampons (1/2 box).Additional information received on 04/26/2019: as per the medical records from the second treating facility, the consumer was transferred and initially admitted to the pediatric intensive care unit (picu) for blood pressure support, fluid management and continuation of antibiotics.A vaginal culture was noted to be positive for methicillin-sensitive staph aureus (most likely what caused the infection) from tampon use.Given the etiology of tss and improvement while in the picu, fluids were discontinued and antibiotics were narrowed to cephalexin and clindamycin.Admitting diagnoses included tss, primary electrolyte abnormality, tachycardia, thrombocytopenia, fever, caogulopathy, acute kidney injury, tachypnea, acute pain and hypotension.Treatment medications included: acetaminophen (tylenol) 500 mg tablet po q4h prn for mild pain on (b)(6) 2019 and 650 mg po q4h prn for temperature above100.4 from (b)(6) 2019, calcium gluconate as salt 50 mg/ml injection dilution 3,000 mg (48.2 mg/kg/dose) iv once on (b)(6) 2019, ceftriaxone (rocephin) 40 mg/ml injection dilution 2000 mg (32.1 mg/kg/dose) iv q24 h on (b)(6) 2019, cephalexin (keflex) capsule 500 mg (8.03 mg/kg/dose) po qid starting on (b)(6) 2019, clindamycin (cleocin) 18 mg/ml injection iv q8h from (b)(6) 2019 and clindamycin capsule 450 mg po qid from (b)(6) 2019, diphenhydramine (benadryl) 25 mg tablet po prn for itching starting on (b)(6) 2019 and famotidine (pepcid) 4 mg/ml inj dilution 20 mg iv q12h starting on (b)(6) 2019, lactated ringers infusion 100 ml/hr iv, continuous starting on (b)(6) 2019, lidocaine-prilocaine (emla) 2.5-2.5 % topical cream once on (b)(6) 2019, magnesium sulfate 40 mg/ml rtu inj 2,000 mg (32.1 mg/kg/dose) iv once on (b)(6) 2019, melatonin tablet 3 mg po, nightly prn, norepinephrine (levophed) 0.02 mg/ml in dextrose 5% in water infusion iv continuous starting on (b)(6) 2019, ondansetron (zofran) 4 mg/2ml inj iv q8h prn nausea, vomiting, pantoprazole (protonix) ec tablet 40 mg, po daily fist dose on (b)(6) 2019, phytonadione (vitamin k) 2 mg/ml iv once on (b)(6) 2019 through (b)(6) 2019, sertraline (zoloft) tablet 50 mg po daily starting (b)(6) 2019, sodium chloride (ocean) 0.65 % nasal spray, 2 sprays each nare q 1h prn congestion starting on (b)(6) 2019, vancomycin (vancocin) 5 mg/ml inj dilution 935 mg iv q6h starting on (b)(6) 2019 through (b)(6) 2019.Discharge medications included: cephalexin 500 mg po qid for 9 days and clindamycin 450 mg po qid for 9 days, both starting on (b)(6) 2019.Additional information received on 06/12/2019: added race, relevant tests and laboratory test results as per the medical record.Tampon was returned by consumer.Quality investigation found no association between the manufacture of the product and the tss incident.

• Brand Name: PLAYTEX SPORT TAMPONS, 36 CT SUPER UNSCENTED
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; 804 walker road; dover DE 19904
• MDR Report Key: 8391103
• MDR Text Key: 137865705
• Report Number: 2515444-2019-00003
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00078300099239
• UDI-Public: 078300099239
• Combination Product (y/n): N
• PMA/PMN Number: K132819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 18206W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 62