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

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.

• 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 Key: 9919070
• MDR Text Key: 197923414
• Report Number: 3007215625-2020-00037
• Device Sequence Number: 1
• Product Code: GFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K) EXEMP
• Number of Events Reported: 1
• 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

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A0029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other