MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-14 for NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB manufactured by Johnson & Johnson Consumer Inc.
[120375562]
Device was used for treatment, not diagnosis. Patient ethnicity and race was not provided for reporting. This report is for one (1) ntg light therapy acne mask usa (b)(4), 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. At this time, with limited information provided, this event is being reported with an overabundance of caution. A supplemental report will be provided upon completion of an investigation to determine if the device is associated with this event. Labeling states do not use light therapy acne mask if you are pregnant, maybe pregnant, or nursing as the risks are unknown and have not been established. 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
[120375563]
A husband reported that on (b)(6) 2018 his wife had 2 positive pregnancy tests. Consumer had been using product in the past weeks while pregnant, expected due date (b)(6) 2019. On (b)(6) 2018 consumer suffered a miscarriage due to ectopic pregnancy and underwent surgery to correct it on the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00046 |
| MDR Report Key | 7878668 |
| Report Source | CONSUMER |
| Date Received | 2018-09-14 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-08-16 |
| Date Added to Maude | 2018-09-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB |
| Generic Name | ACNE LIGHT THERAPY SYSTEM |
| Product Code | OLP |
| Date Received | 2018-09-14 |
| Model Number | 70501101247 |
| 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. Death | 2018-09-14 |