MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-01-11 for NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT 6907376834465 manufactured by Johnson & Johnson Consumer Inc.
[132794410]
Device was used for treatment, not diagnosis. Patient age at time of event, sex, 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 spot treatment usa 70501101315). This report is for (neutrogena visibly clear light therapy spot treatment ap 6907376834465, 26202392apa, 26202392apa). Device is not distributed in the united states, but is similar to device marketed in the usa (ntg light therapy acne spot treatment usa 70501101315). (b)(4). 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 70501101315). 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
[132794411]
It was reported that the consumer experienced an allergy after using the neutrogena light therapy acne spot treatment. The consumer sought medical attention. No additional information has been provided or received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2019-00059 |
| MDR Report Key | 8238764 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-01-11 |
| Date of Report | 2018-12-13 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-01-11 |
| 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 | CHANTOU 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 | 2019-01-11 |
| Model Number | 6907376834465 |
| 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 | 2019-01-11 |