MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-23 for NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT 70501101315 manufactured by Johnson & Johnson Consumer Inc.
[133862434]
Device was used for treatment, not diagnosis. Patient age, sex, weight, ethnicity and race was not provided for reporting. This report is for one (1) ntg light therapy acne spot treatment usa (b)(4). Lot # is not available. (b)(4), expiration date= ni, lot number = ni. Device is not expected to be returned for manufacturer review/investigation. Device evaluation 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. At this time, with limited information provided, this event is being reported with an overabundance of caution. (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
[133862435]
A consumer reported an incident after using the neutrogena light therapy acne spot treatment. Consumer has been using the device for two days for his/her pigment; however, the consumer alleged it has only made it worse. Consumer states that his/her skin is even more dry and red and burns. The consumer also states that he/she has been having severe headaches. Consumer's dermatologist has been giving the consumer multiple prescriptions and the symptoms have not resolved. Consumer states that his/her face is getting worse.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2214133-2019-00061 |
MDR Report Key | 8270858 |
Report Source | CONSUMER |
Date Received | 2019-01-23 |
Date of Report | 2018-12-29 |
Date Mfgr Received | 2018-12-29 |
Date Added to Maude | 2019-01-23 |
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 LIGHT THERAPY ACNE SPOT TREATMENT |
Generic Name | OTC POWERED LIGHT BASED LASER FOR ACNE |
Product Code | OLP |
Date Received | 2019-01-23 |
Model Number | 70501101315 |
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 | 2019-01-23 |