MAUDE MDR 5003088

MDR report key
5003088
Report number
3005128563-2015-00001
Event key
0
Event type
3
Date of event
2015-07-01
Date received
2015-08-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
660 WHITE PLAINS RD TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1E.P.T. ANALOG EARLY PREGNANCY TESTHCG PREGNANCY TEST, OTCAKERE (SHANGHAI) DIAGNOSTICS CO., LTD.LCXUNKUNKUNK* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-1101. O

Event Narratives#

D

Patient 1

THE MOTHER REPORTED HER DAUGHTER USED ONE E.P.T. ANALOG EARLY PREGNANCY TEST ONCE, VAGINALLY, TO TEST FOR POSSIBLE PREGNANCY ON (B)(6) 2015. ON (B)(6) 2015, CONTRARY TO THE PRODUCT'S INSTRUCTIONS FOR USE, THE PATIENT INSERTED TEST INTO VAGINA, THE TEST BECAME STUCK. WHEN SHE ATTEMPTED TO REMOVE IT, SHE TORE HER VAGINAL WALL AND BEGAN TO EXPERIENCE VAGINAL BLEEDING. THE MOTHER TOOK HER TO THE HOSPITAL WHERE THEY SEDATED HER, REMOVED THE TEST SURGICALLY AND GAVE HER SOME PAIN KILLERS AND CREAM. AT THE HOSPITAL, PATIENT WAS CONFIRMED PREGNANT BY A BLOOD TEST. THE MOTHER REPORTS HER DAUGHTER WAS NOT ADMITTED AND WAS AT THE HOSPITAL FOR TREATMENT FOR LESS THAN 24 HOURS. THE MOTHER REPORTED THAT HER DAUGHTER IS CURRENTLY NOT TAKING MEDICATIONS AND HAS NO MEDICAL HISTORY. THE MOTHER REPORTED THAT HER DAUGHTER WAS PREGNANT WHEN SHE USED THE E.P.T. ANALOG EARLY PREGNANCY TEST. THE PATIENT'S PREGNANCY DUE DATE IS UNK.