MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for BEAUTY ANGEL RVT30 NA manufactured by Jk Products & Services.
[38637084]
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.
Patient Sequence No: 1, Text Type: N, H10
[38637105]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2311923-2016-00001 |
| MDR Report Key | 5448671 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-19 |
| Date of Event | 2015-12-17 |
| Date Facility Aware | 2016-01-21 |
| Date Mfgr Received | 2016-01-21 |
| Date Added to Maude | 2016-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHEAL CRAIG |
| Manufacturer Street | 1 WALTER KRATZ DRIVE |
| Manufacturer City | JONESBORO AR 72401 |
| Manufacturer Country | US |
| Manufacturer Postal | 72401 |
| Manufacturer Phone | 8709351130 |
| Manufacturer G1 | JK PRODUCTS & SERVICES |
| Manufacturer Street | 1 WALTER KRATZ DRIVE |
| Manufacturer City | JONESBORO AR 72401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BEAUTY ANGEL |
| Generic Name | MASSAGER, THERAPEUTIC, ELECTRIC |
| Product Code | ISA |
| Date Received | 2016-02-19 |
| Model Number | RVT30 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JK PRODUCTS & SERVICES |
| Manufacturer Address | 1 WALTER KRATZ DRIVE JONESBORO AR 72401 US 72401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-19 |