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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PACIFIC BIOSCIENCE LAB INC. CLARISONIC; ULTRASONIC CLEANER
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PACIFIC BIOSCIENCE LAB INC. CLARISONIC; ULTRASONIC CLEANER Back to Search Results
Lot Number 0095LK
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Peeling (1999); Swelling (2091); Swelling (2091); Burning Sensation (2146); Discomfort (2330); Discomfort (2330); Reaction (2414); Reaction (2414); Alteration In Body Temperature (2682); Alteration In Body Temperature (2682)
Event Date 04/27/2016
Event Type  Injury  
Event Description
Initial information was received on 04/28/2016 and was processed with additional information received on 06/13/2016.The case has been reassessed as serious based upon new information received on 06/13/2016.This spontaneous report was received on 04/28/2016 from a (b)(6) caucasian female consumer reporting on self from the united states of america.The medical history included seasonal allergies.The concomitant medications included generic zyrtec (cetirizine) one tab daily since three weeks for season allergies.The reported weight of the consumer was 52 kilograms.On (b)(6) 2018, the consumer started using neutrogena naturals fresh cleansing makeup remover topically, nickle size amount, at night used twice to clean the face (lot number 0095lk and expiration date unspecified) with clarisonic (wrong technique in product usage process) topically to clean the face (frequency, lot number and expiration date unspecified).On the next morning, the consumer developed swelling on face.She reported that, the product did not agree with her skin and she felt uncomfortable.On the same day, the consumer again used the product in night and on the next day,she woke up with a very swollen, warm face which consumer described as felt like sunburn.The product was not used further.She said that her face feels better but looks worse.She treated the swelling with a double dose of an antihistamine.On (b)(6) 2016, the consumer consulted healthcare professional and was diagnosed with allergic dermatitis and prescribed with dapomedrol (methylprednisolone) 40 mg/ml injection and hydrocortisone 2.5 percent creams.The consumer stated that she usually purchased the product without make up remover but accidentally purchased this product with makeup remover (wrong product selected).The action taken with the clarisonic was unknown.On (b)(6) 2016, all the events resolved.This report was assessed as serious (medically significant) and company causality was assessed as possible.Dose: nickel size, twice, topical.Therapy dates: (b)(6) 2016.Event abated after use stopped or dose reduced: yes.
 
Event Description
(b)(4).Add'l info received from reporter on 08/16/2016 from physician for mw5063447: the reported height of the consumer was (b)(6).The social history included alcohol consumption occasionally.On (b)(6) 2016, the consumer visited the physician with itching, burning, peeling and rash and the physician diagnosed it as contact dermatitis and urticaria and was prescribed depomedrol (methylprednisolone) 40mg/ml injection (route unspecified) and hydrocortisone 2.5% cream, topically, twice per day, to treat the events.The consumer also stated that consumer accidentally purchased this product with makeup remover and used along with clarisonic.This report remains serious (medically significant).The company causality was assessed as probable for contact dermatitis and urticaria and possible for other events.
 
Event Description
Initial information was received on 04/28/2016 and was processed with additional information received on 06/13/2016.The case has been reassessed as serious based upon new information received on 06/13/2016.This spontaneous report was received on 04/28/2016 from a (b)(6) caucasian female consumer reporting on self from the united states of america.The medical history included seasonal allergies.The concomitant medications included generic zyrtec (cetirizine) one tab daily since three weeks for season allergies.The reported weight of the consumer was 52 kilograms.On (b)(6) 2018, the consumer started using neutrogena naturals fresh cleansing makeup remover topically, nickle size amount, at night used twice to clean the face (lot number 0095lk and expiration date unspecified) with clarisonic (wrong technique in product usage process) topically to clean the face (frequency, lot number and expiration date unspecified).On the next morning, the consumer developed swelling on face.She reported that, the product did not agree with her skin and she felt uncomfortable.On the same day, the consumer again used the product in night and on the next day,she woke up with a very swollen, warm face which consumer described as felt like sunburn.The product was not used further.She said that her face feels better but looks worse.She treated the swelling with a double dose of an antihistamine.On (b)(6) 2016, the consumer consulted healthcare professional and was diagnosed with allergic dermatitis and prescribed with dapomedrol (methylprednisolone) 40 mg/ml injection and hydrocortisone 2.5 percent creams.The consumer stated that she usually purchased the product without make up remover but accidentally purchased this product with makeup remover (wrong product selected).The action taken with the clarisonic was unknown.On (b)(6) 2016, all the events resolved.This report was assessed as serious (medically significant) and company causality was assessed as possible.Dose: nickel size, twice, topical.Therapy dates: (b)(6) 2016.Event abated after use stopped or dose reduced: yes.
 
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Brand Name
CLARISONIC
Type of Device
ULTRASONIC CLEANER
Manufacturer (Section D)
PACIFIC BIOSCIENCE LAB INC.
MDR Report Key5801865
MDR Text Key49985096
Report NumberMW5063447
Device Sequence Number1
Product Code FLG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Not Applicable
Type of Report Initial,Followup
Report Date 06/24/2016
1 Device was Involved in the Event
2 Patient was Involved in the Event
Date FDA Received06/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number0095LK
Is the Reporter a Health Professional? No
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Other;
Patient Age42 YR
Patient Weight52
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