MAUDE Adverse Event Report: JK PRODUCTS & SERVICES BEAUTY ANGEL; MASSAGER, THERAPEUTIC, ELECTRIC

Model Number RVT30

Device Problem Use of Device Problem (1670)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Discoloration (2074); Blurred Vision (2137); Visual Disturbances (2140)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

According to the information we have, the patient hasn't paid attention to the warning labels which are visible at the eye level upon entering the appliance (see attachment jk part no.1014466-00) the label states "protective eye wear such as sunglasses or other light reducing eye wear is recommended for people who are sensitive to bright light." additionally in the manual this statement is also given reference (page 22/5.3).We have verified our bill of materials includes this label, reviewed our manufacturing instruction for applying this label, and sample finished goods to verify the label is applied and in the correct position.Without additional information as to the exact location of this appliance, we feel we have performed due diligence in reference to this incident.It is our opinion the pt either overlooked the label indicating the use of eye protection or disregarded it altogether.Note: the statements in the report referring to the beauty angel as a tanning bed are not correct.The beauty angel is not a tanning bed with classification name: "sun booth." there are no ultraviolet lamps assembled.Location of device unknown.

Event Description

Complaint received from medwatch report #mw5058791.Pt called to report an adverse reaction on (b)(6) 2015, to a device called beauty angel.Pt stated, she used the device at a local plant fitness, and nowhere did she see any warning that said to wear eye protection when using the device pt said on (b)(6) 2015, she was driving and noticed vision changes.Pt said all the lights on the road were glaring, her peripheral vision was blurry, and she developed a headache.Pt said the corners of her eyes felt very painful, and that the skin around her eyes was sore.On (b)(6) 2015, the pt said she finally realized her vision changes were getting worse so she went to see an eye doctor.She said the eye doctor confirmed her vision changes, but could not confirm if the damage was temporary or permanent.Pt said she was referred to a retina specialist, but has not been able to schedule and appointment yet.The pt also said the skin on her face changed, here freckles became more noticeable, even though she had put a t-shirt over her face.

• Brand Name: BEAUTY ANGEL
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): JK PRODUCTS & SERVICES; 1 walter kratz drive; jonesboro AR 72401
• Manufacturer (Section G): JK PRODUCTS & SERVICES; 1 walter kratz drive; jonesboro AR 72401
• Manufacturer Contact: micheal craig ; 1 walter kratz drive; jonesboro, AR 72401 ; 8709351130
• MDR Report Key: 5448671
• MDR Text Key: 38637084
• Report Number: 2311923-2016-00001
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RVT30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/21/2016
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other