MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-19 for NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT 70501101315 manufactured by Johnson & Johnson Consumer Inc.
[139824623]
Device was used for treatment, not diagnosis. Patient age, weight, ethnicity and race was not provided for reporting. This report is for one (1) ntg light therapy acne spot treatment usa 70501101315. Lot # is not available. Udi # (b)(4), upc: (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. 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
[139824624]
A female consumer reported an event with the ntg light therapy acne spot treatment usa. The consumer was using the ntg light therapy acne spot treatment for a small pimple on her face. The consumer has alleged that the ntg light therapy acne spot treatment started to smell and spark. Consumer alleged burn to face and middle finger on her right hand. Consumer stated that her face and finger blistered and a week after the event she still had marks on both her face and finger. Consumer received medical attention while at her place of employment, an emergency room (er). Consumer was told to keep applying an unknown antibiotic cream to prevent infection and that it will take time to heal the burn and broken skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2019-00065 |
| MDR Report Key | 8433696 |
| Report Source | CONSUMER |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-23 |
| Date Mfgr Received | 2019-02-23 |
| Date Added to Maude | 2019-03-19 |
| 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 |
| 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 | 2019-03-19 |
| 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 | 2019-03-19 |