NEUTROGENA MICRODERMABRASION SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-04 for NEUTROGENA MICRODERMABRASION SYSTEM manufactured by Jnj Consumer Us Cosmetic.

Event Text Entries

[129507600] This spontaneous report was received from a (b)(6) y/o female pt reporting on self from the united states (b)(6). The pt's weight was (b)(6). The pt's medical history and concurrent conditions included blood pressure problem, heart disorder (arteries problems) and thyroid disorder. The pt did not have any allergies. On (b)(6) 2018, first time, the pt started using neutrogena microdermabrasion system (topical, batch 1318rda3) just one pad, just that one time as cleanse. On (b)(6) 2018, the pt reported that product burnt her face. Her face was blood red, itchy and was peeling due to which she had to miss her work. She did not experienced similar reaction before. On an unspecified date in (b)(6) 2018, she visited to dr who gave one shot of a steroid shot and a benadryl shot (injection). Action taken with neutrogena microdermabrasion system was not applicable. The outcome was not resolved for event itchy face, red face, peeling of skin and for burnt face. This report did not meet product quality complaint criteria and does not involve a product quality complaint. This report was serious (medically significant). Application sites - burn, pruritus. Dose: just one pad just that one time, topical. Therapy dates: (b)(6) 2018 - (b)(6) 2018. Diagnosis for use: removal of inert matter from skin or subcutaneous tissue. Mfr report number: (b)(4). Date received by mfr: 11/12/2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081835
MDR Report Key8133519
Date Received2018-12-04
Date of Report2018-11-28
Date of Event2018-11-05
Date Added to Maude2018-12-05
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 NameNEUTROGENA MICRODERMABRASION SYSTEM
Generic NameNEUTROGENA MICRODERMABRASION SYSTEM
Product CodeGED
Date Received2018-12-04
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerJNJ CONSUMER US COSMETIC
Manufacturer Address199 GRANDVIEW RD SKILLMAN NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-12-04

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