PREGNANCY TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-14 for PREGNANCY TEST manufactured by Unk.

Event Text Entries

[100802826] On (b)(6) 2015, i had a full term still birth, unable to obtain prenatal care throughout the pregnancy and unable to obtain delivery assistance when my water broke due to a false pregnancy tests. A (b)(6) ob/gyn requested that i obtained uterine measurements and a hormone analysis if this situation happens again. That same ob/gyn was no longer available at (b)(6). On (b)(6) 2018, i went to see dr (b)(6) at (b)(6). Dr (b)(6) viewed the results of the urine pregnancy test. She showed me where the uterine fundus would be if i was 24 weeks pregnant. I nodded but didn't cry out in pain, because i am used to that check. She claimed my uterus was down low and showed me a blurry ultrasound of something that was not my uterus. No fetus and no uterine fibroids. Last ultrasound, before endometrial biopsy showed fibroids in sizes of time, grapefruit, and papaya. The fibroids are dark black and can't be missed. Also no endometrial lining was visible at all. At my oldest daughter's urging, i scheduled at appointment at (b)(6). On (b)(6) 2018, i went to see fnp (b)(6) at (b)(6). My oldest daughter went with me to make sure i was treated fairly. Fnp (b)(6) viewed the results of the urine pregnancy test and requested a quantitative serum pregnancy test. She said i would need to schedule an expanded visit to have the size of my uterus checked. (b)(6) 2018 now 27 wks pregnant, i went to see fnp (b)(6) at (b)(6) for an expanded visit and pelvic exam with the goal to have a uterine measurement. My daughter and i had mentioned the fda guidelines for the pregnancy test. (b)(6) had verified this was true and sent a letter to the fda requesting more info and asking when the test was changed. I asked the nurse who checked me in if (b)(6) continued to require a positive pregnancy test to receive prenatal care. The nurse firmly said it was required. I expected to undress for the pelvic exam, but waited until being told to do so. I was not told to undress and was not given a gown. Fnp (b)(6) examined me fully clothed. She said she could not locate a definite uterine fundus and gave me a referral for an ultrasound. I've scheduled an appointment at a mid-wife service to see what they can do and scheduled an ultrasound for this friday. My oldest daughter is concerned that i'm running up against the same problems. I had last pregnancy. Three visits so far and the simple request of uterine measurement has not been done, because drs are focusing on the results of the pregnancy tests.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075276
MDR Report Key7273443
Date Received2018-02-14
Date of Report2018-02-13
Date of Event2018-02-10
Date Added to Maude2018-02-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePREGNANCY TEST
Generic NamePREGNANCY TEST
Product CodeLCX
Date Received2018-02-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-14

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