ENDOMETRIAL BIOPSY TOOL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for ENDOMETRIAL BIOPSY TOOL manufactured by Unk.

Event Text Entries

[144415972] I was a (b)(6) woman with normal ovarian reserve but dr (b)(6) pushed highest starting doses of 450 iu fsh, plus a lot of lupron injections that resulted in horrible skin rashes. Skin rashes appeared when lupron injections were ordered as a part of ivf (b)(6) 2017 - (b)(6) 2017. Dr (b)(6) ordered lupron injections again for some study test era cycle (b)(6) 2017 - (b)(6) 2017. More lupron injections were given for fet cycle (b)(6) 2017 - (b)(6) 2017. I am still recovering. Other serious/important medical incident: moderate ovarian hyperstimulation syndrome with bloating, abnormal pain; terrible skin rashes. Highest fsh dose 450 iu given by dr (b)(6) as 300iu follistim + 150 iu menopur during (b)(6) 2017, two weeks of lupron injections given too. I bought all ivf medication from glen rock pharmacy, design rx. I was told that estimating hormone levels are necessary and demanded by fda regulations; however, dr (b)(6) misdiagnosed with poor ovulation to push his copy and paste aggressive ivf protocol with 450 iu fsh. Dr (b)(6) performed terrible endometrial scratching without showing that sharp object. Unprofessional. Unnecessary but terrible endometrial scratching performed by sharp tool. I have no idea what kind of sharp tool was used during horrible biopsy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086399
MDR Report Key8582773
Date Received2019-05-03
Date of Report2019-04-24
Date of Event2017-09-22
Date Added to Maude2019-05-06
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 NameENDOMETRIAL BIOPSY TOOL
Generic NameCURETTE, UTERINE
Product CodeHCY
Date Received2019-05-03
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 2019-05-03

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