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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PLEASANTON); BRUSH, DERMABRASION, POWERED

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ALLERGAN (PLEASANTON); BRUSH, DERMABRASION, POWERED Back to Search Results
Catalog Number A0029
Device Problem Unintended Electrical Shock (4018)
Patient Problem Electric Shock (2554)
Event Type  Injury  
Manufacturer Narrative
The silkpeel pro dermalinfusion system is an advanced skin-resurfacing technology device indicated to exfoliate, extract, and infuse condition-specific serums to improve skin health, function, and appearance.Based on the information currently available, a serious injury possibly caused by an electric shock, has occurred from the power supply used during a silkpeel pro dermalinfusion treatment.The silkpeel pro dermalinfusion system user manual states, "caution: to reduce the risk of electrical shock, do not remove the cover.Refer servicing to qualified service personnel.Use only with mw136ra1203f01 external power supply module." allergan has conducted due diligence to obtain information required for the complaint investigation, but no information has been received.Allergan will continue to closely monitor trending data and will consider further action if deemed necessary.A supplemental report will be submitted if/when additional information is received.
 
Event Description
Allergan received a report from a provider that while using the silkpeel pro dermalinfusion system, the power supply was damaged and had come apart.The operator of the machine was lightly shocked a couple of times.
 
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Type of Device
BRUSH, DERMABRASION, POWERED
Manufacturer (Section D)
ALLERGAN (PLEASANTON)
4410 rosewood drive
pleasanton, ca
Manufacturer Contact
jennifer cleto
4410 rosewood drive
pleasanton, ca 
6214130
MDR Report Key9919070
MDR Text Key197923414
Report Number3007215625-2020-00037
Device Sequence Number1
Product Code GFE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510(K) EXEMP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA0029
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/03/2020
Initial Date FDA Received04/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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