SURE-AID 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 2019-05-16 for SURE-AID PREGNANCY TEST manufactured by Unk.

Event Text Entries

[145617479] Pregnancy test invalid. Both times. First box showed no result, blank. Serial no: (b)(4); second turned on almost immediately and went invalid after a few seconds:(b)(4). Second serial number is: (b)(4) and matching numbers on both. Lot no: 006182, "exp mr2021. " exclusively distributed by (b)(4). Name of the company that makes (or compounds) the product: insight pharmaceutical, llc. Reason for use: late period. Quantity: 2 sticks. How was it taken or used? Pee on stick.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5086711
MDR Report Key8620041
Date Received2019-05-16
Date of Report2019-05-14
Date of Event2019-05-14
Date Added to Maude2019-05-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameSURE-AID PREGNANCY TEST
Generic NameKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
Product CodeLCX
Date Received2019-05-16
Lot Number006182
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 2

Brand NameSURE-AID PREGNANCY TEST
Generic NameKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
Product CodeLCX
Date Received2019-05-16
Lot Number006182
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-16
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