MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-24 for NEUTROGENA? LIGHT THERAPY ACNE MASK 062600965035 manufactured by Johnson & Johnson Consumer Inc.
[146066674]
Ethnicity: patient ethnicity and race was not provided for reporting. Brand name: device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne mask usa). Common device name, procode, mfr, lot #, expiration date, part #: this report is for (ntg light therapy acne mask can 62600965035). Device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne mask usa 70501101247). Lot# and expiration date is unknown. (b)(4). Device available for evaluation: device is not expected to be returned for manufacturer review/investigation. Device evaluated by mfr, manufacture date: device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer and a product lot number was not reported. (b)(4). 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
[146066675]
A female consumer reported following the use of the neutrogena light therapy acne mask she experienced an acne breakout. The consumer continued to use the product for two additional sessions and noted that she experienced cystic pimples with white pus and redness. The consumer noted they used 3-4 sessions in total and experienced the reaction after the first use. The consumer stopped using the product and purchased treatment from the pharmacy (over the counter medication and creams). The consumer also noted she had scars and was experiencing severe acne that required consultation with a dermatologist. Treatment by the dermatologist will include micro-needling sessions and accutane (prescription).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2019-00076 |
| MDR Report Key | 8640322 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-24 |
| Date of Report | 2019-04-30 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-24 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUTROGENA? LIGHT THERAPY ACNE MASK |
| Generic Name | ACNE LIGHT THERAPY SYSTEM |
| Product Code | OLP |
| Date Received | 2019-05-24 |
| Model Number | 062600965035 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-24 |