MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-03 for NTG LIGHT THERAPY ACNE SPOT TREATMENT 70501101315 manufactured by Johnson & Johnson Consumer Inc.
| Report Number | 2214133-2019-00116 |
| MDR Report Key | 9150357 |
| Report Source | CONSUMER |
| Date Received | 2019-10-03 |
| Date of Report | 2019-09-05 |
| Date Mfgr Received | 2019-09-05 |
| Date Added to Maude | 2019-10-03 |
| 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 | NTG LIGHT THERAPY ACNE SPOT TREATMENT |
| Generic Name | OTC POWERED LIGHT BASED LASER FOR ACNE |
| Product Code | OLP |
| Date Received | 2019-10-03 |
| 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 | 2019-10-03 |