MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-08-28 for NEUTROGENA LIGHT THERAPY ACNE MASK AP 26202031B manufactured by Johnson & Johnson Consumer Inc.
Report Number | 2214133-2019-00099 |
MDR Report Key | 8941825 |
Report Source | CONSUMER,FOREIGN |
Date Received | 2019-08-28 |
Date of Report | 2019-08-01 |
Date Mfgr Received | 2019-08-01 |
Date Added to Maude | 2019-08-28 |
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 MASK AP |
Generic Name | ACNE LIGHT THERAPY SYSTEM |
Product Code | OLP |
Date Received | 2019-08-28 |
Model Number | 26202031B |
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 | 2019-08-28 |