MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-07-03 for NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU AN3LTCMA91806 manufactured by Johnson & Johnson Consumer Inc.
[113053875]
Device was used for treatment, not diagnosis. Patient weight was not provided for reporting. This report is for (neutrogena visibly clear light therapy acne mask (b)(4)). Device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne mask kit usa (b)(4)). (b)(4). Device is not expected to be returned for manufacturer review/investigation. Concomitant medical products and therapy dates: ebastel, consumer still on drug. Device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne mask kit usa (b)(4)). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. A review of the device history records has been requested. 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
[113053876]
A mother of a (b)(6) daughter reported that her daughter has used the neutrogena visibly clear light therapy acne mask for 10 minutes daily and on the 4th day, (b)(4) 2018, the consumer noticed as if her face was burned. The consumer visited the hospital emergency room because she saw the burns on the cheekbones, nose, chin and forehead. The doctor recommended the patient to use a moisturizer (avene creme) and maximum sun protection to avoid possible spots after the desquamation. It was reported that consumer? S face skin is recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00025 |
| MDR Report Key | 7659146 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-07-03 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-06-03 |
| Date Mfgr Received | 2018-07-12 |
| Date Added to Maude | 2018-07-03 |
| 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 | 2018-07-03 |
| Model Number | AN3LTCMA91806 |
| Lot Number | 3417KS06 |
| ID Number | (01)AN3LTCMA91806 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-03 |