MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-27 for NEUTROGENA? LIGHT THERAPY ACNE MASK 070501101247 manufactured by Kinseng Plastics Co. Ltd..
[103607887]
Device was used for treatment, not diagnosis. (b)(4). Concomitant medical products and therapy dates: drug: klonopin; as need; 2-3 years; to treat panic; anxiety disorder; consumer still on drug: wellbutrin; 1x daily; 2-5 years; to treat depression; consumer still on drug. (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. A review of the device history records has been requested. 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
[103607888]
Consumer reported that after using the acne mask she experienced splotches, rash, sores, welts, inflamed red blotches and large painful bumps that covered her face and neck. Consumer was in pain from the outbreak and claims that the mask burned and wrinkled her skin and caused multiple lines on her forehead. Consumer experienced depression since use of the mask. Consumer is recovering but still has a rash and bumps on her face and neck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00004 |
| MDR Report Key | 7375038 |
| Report Source | CONSUMER |
| Date Received | 2018-03-27 |
| Date of Report | 2018-03-29 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2018-03-27 |
| 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 | PINBEI INDUSTRIAL AREA MIANBEI STREET OFFICE |
| Manufacturer City | SHANTOU CITY |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUTROGENA? LIGHT THERAPY ACNE MASK |
| Generic Name | ACNE LIGHT THERAPY SYSTEM |
| Product Code | OLP |
| Date Received | 2018-03-27 |
| Model Number | 070501101247 |
| Catalog Number | NI |
| Lot Number | 2146KS05 |
| ID Number | (01)070501101247 |
| Device Expiration Date | 2018-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KINSENG PLASTICS CO. LTD. |
| Manufacturer Address | PINBEI INDUSTRIAL AREA MIANBEI STREET OFFICE SHANTOU CITY CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-27 |