MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-05-24 for NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU AN3LTCMA11836 manufactured by Kinseng Plastics Co. Ltd..
[109166844]
Device was used for treatment, not diagnosis. Weight and ethnicity 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). (b)(4). Lot # was not provided. Device is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne mask usa). (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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
[109166848]
A consumer called about the neutrogena visibly clear light therapy acne mask she was using for acne treatment. The consumer started using the device on (b)(6) 2017 for daily treatment. Since (b)(6) 2017 she is alleging that her eyes have been dry and that she is sensitive to the sunlight. Consumer was seen by a health care professional who prescribed cortisone for treatment. Consumer has also been using a tear substitute for 2-3 months. Consumer is alleging damage to the corneas and symptoms associated with the disease sicca (dry eyes). Symptoms have not resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00007 |
| MDR Report Key | 7541221 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-05-24 |
| Date of Report | 2018-04-30 |
| Date of Event | 2017-09-30 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-05-24 |
| 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 | 2018-05-24 |
| Model Number | AN3LTCMA11836 |
| ID Number | (01)AN3LTCMA11836 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KINSENG PLASTICS CO. LTD. |
| Manufacturer Address | PINBEI INDUSTRIAL AREA MIANBEI STREET OFFICE SHANTOU CITY CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-24 |