MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-14 for NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT 3574661383613 manufactured by Johnson & Johnson Consumer Inc.
[186841748]
Device was used for treatment, not diagnosis. Patient identifier, age at time of event, weight and ethnicity and race were not provided for reporting. This report is for (neutrogena light therapy acne spot treatment 1s eu 3574661383613 3574661383613eua 3574661383613eua). Device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne spot treatment usa (b)(4). Udi #: (b)(4), lot # 2268ks04. 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 spot treatment 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
[186841749]
A female teenage consumer of unspecified age reported an event with ntg light therapy spot acne treatment. It was initially reported that she developed? Burns on the lips and eyes and has been under observation in the hospital?. Upon further information, from her pharmacist, it was clarified that the consumer developed a? Very irritated eyes? In the school and the mother brought the consumer to emergency room (er) and she was placed on observation. No further information was provided. The consumer was supposedly later taken to an ophthalmologist for consult at an unspecified time. There is no information on results of any diagnostics done, diagnosis, treatment and outcome. There were no details provided on the medical history nor any concomitant medications being taken or device usage such as frequency, time and duration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2020-00002 |
| MDR Report Key | 9586654 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2018-08-14 |
| Date Added to Maude | 2020-01-14 |
| 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 | LAURIE RAUCO |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152734905 |
| 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 LIGHT THERAPY ACNE SPOT TREATMENT |
| Generic Name | OTC POWERED LIGHT BASED LASER FOR ACNE |
| Product Code | OLP |
| Date Received | 2020-01-14 |
| Model Number | 3574661383613 |
| Lot Number | 2268KS04 |
| 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 NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-14 |