MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-10 for NEUTROGENA? LIGHT THERAPY ACNE MASK 070501101247 manufactured by Kinseng Plastics Co. Ltd..
[91855678]
Device was used for treatment, not diagnosis. Date of birth and weight were not provided for reporting. Exact date of the event is unknown. Consumer reported the event occurred several weeks prior to the j and j awareness date. (b)(4). Device is not expected to be returned for manufacturer review/investigation. Device history records review was completed. No non conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
[91855679]
On an unspecified date, in 2017, few weeks prior to reporting, the consumer started using neutrogena light therapy acne mask. After using it for about 10 seconds her eyes started burning and hurting. She tried it for another short while (less than a minute) with a thick sock covering eyes but it was still painful. Afterwards her vision was blurry, eyes were painful and eyelids were hot and puffy. On an unspecified date, in 2017, she visited er (emergency room) where she was diagnosed with optic neuritis. She was prescribed unspecified ointment to put in eyes. While reporting the consumer mentioned that her vision mostly returned to normal although there still was some excessive light sensitivity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2017-00008 |
| MDR Report Key | 7018563 |
| Date Received | 2017-11-10 |
| Date of Report | 2017-10-13 |
| Date Mfgr Received | 2017-10-13 |
| Device Manufacturer Date | 2016-08-29 |
| Date Added to Maude | 2017-11-10 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NI LINDA PLEWS |
| Manufacturer Street | 199 GRANDVIEW RD NI |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152737120 |
| Manufacturer G1 | KINSENG PLASTICS CO. LTD. |
| Manufacturer Street | UNKNOWN NI |
| Manufacturer City | SHANTOU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEUTROGENA? LIGHT THERAPY ACNE MASK |
| Generic Name | ACNE LIGHT THERAPY SYSTEM |
| Product Code | OLP |
| Date Received | 2017-11-10 |
| Model Number | 070501101247 |
| Catalog Number | NI |
| Lot Number | 2426KS06 |
| ID Number | (01)070501101247 |
| Device Expiration Date | 2018-08-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KINSENG PLASTICS CO. LTD. |
| Manufacturer Address | UNKNOWN NI SHANTOU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-10 |