MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-10-17 for NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU 070501101247 manufactured by Johnson & Johnson Consumer Inc.
[124004354]
Device was used for treatment, not diagnosis. Patient age at time of event, weight and ethnicity and race were not provided for reporting. Device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne mask usa). This report is for (neutrogena visibly clear light therapy acne mask eu). Device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne mask usa 70501101247 7050110124usb 7050110124usb). Udi: (b)(4). Upc = (b)(4). Expiration date= (17) 04/30/2020. Lot number = (10) 1287ks06. The device was received and the product evaluation is in progress. No conclusion can be drawn. A visual inspection of the device does not show any anomalies and the reported lot number is the same as on the product received. When the cable was plugged into the activator it showed 29 sessions remaining. A device history records review was completed. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[124004355]
A female consumer reported she tried the neutrogena visibly clear light therapy acne mask for acne treatment on (b)(6) 2018 and it disturbed her eyes. She used the product once but had 4 occasions when she lost her vision for approximately 5 minutes. Consumer has reported that she had eye surgery prior to using the mask on (b)(6) 2016. This was a laser surgery to correct defective vision. She said that after that surgery, she already had general light sensitivity and a few occasions, where she "unregularly" lost visions for short times (e. G. Also in bright sun light). The neutrogena visibly clear light therapy acne mask was used only once on (b)(6) 2018 with closed eyes. Afterwards she had again loss of vision, unregularly for in total 4 times (exact duration is unknown, initial report indicates 5 minutes) and more intense/longer in duration as before using the mask. Overtime it got less intense and duration shortened. The consumer still has a similar light sensitivity as after the surgery and in general avoids direct light exposure. The consumer sought medical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00047 |
| MDR Report Key | 7974639 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-10-17 |
| Date of Report | 2018-11-07 |
| Date Mfgr Received | 2018-11-07 |
| Device Manufacturer Date | 2017-05-08 |
| Date Added to Maude | 2018-10-17 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152737120 |
| Manufacturer G1 | KINSENG PLASTICS CO. LTD. |
| Manufacturer Street | PINBEI INDUSTRIAL AREA MIANBEI STREET OFFICE |
| Manufacturer City | SHANTOU CITY |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU |
| Generic Name | ACNE LIGHT THERAPY SYSTEM |
| Product Code | OLP |
| Date Received | 2018-10-17 |
| Returned To Mfg | 2018-10-02 |
| Model Number | 070501101247 |
| Lot Number | 1287KS06 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-17 |