MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-04-10 for NEUTROGENA? LIGHT THERAPY ACNE MASK 070501101247 manufactured by Kinseng Plastics Co. Ltd..
[105294689]
Device was used for treatment, not diagnosis. (b)(4). The power cord used to connect the mask to the activator was visibly damaged including significant twisting of the internal power cords. The damage to the cord appeared consistent with the consumer's allegation of a burn to the cord. Upon investigation of the returned product, it was noted that the probable cause of the burn was an electrical short resulting in heating of the power conductors. The burned/damaged section of the cord was removed and the non-damaged portions were re-connected. Once re-connected the cord was able to power the mask through a completed dose with no heating or burning occurring. The power cord from a new mask was cut to compare the condition of the power cables. It was determined that the cables were not twisted on a new mask as they were on the returned mask sample and therefore the cable may have undergone repetitive twisting after manufacturing. Additional investigation is being performed by the manufacturer. A review of the manufacturing records indicate the product met specification at the time of release. Based on the results of the manufacturing investigation and the evaluation of the returned sample, the damage to the cord occurring after the release of the product cannot be ruled out. 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
[105294690]
A female consumer, who is (b)(6) has alleged while using the neutrogena light therapy acne mask on (b)(6) 2018 that the light mask caught on fire. Consumer stated she had the activator in the pocket of her robe and approximately half way through the 10 minute session, the cord started on fire and burned a bit through her robe. She grabbed the cord to disconnect it from the activator and mask. Some of the material from the cord stuck to her finger. She noticed that she had a blister on her finger. Consumer did not treat the blister. The blister on her finger is improving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00005 |
| MDR Report Key | 7411225 |
| Report Source | CONSUMER |
| Date Received | 2018-04-10 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-03-11 |
| Date Mfgr Received | 2018-04-20 |
| Device Manufacturer Date | 2016-06-29 |
| Date Added to Maude | 2018-04-10 |
| 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 | 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 | 2018-04-10 |
| Returned To Mfg | 2018-03-22 |
| Model Number | 070501101247 |
| Catalog Number | NI |
| Lot Number | 1816KS01 |
| ID Number | (01)070501101247 |
| Device Expiration Date | 2018-06-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-10 |