NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB
Received Sep 14, 2018 · Event occurred Aug 16, 2018
Report 2214133-2018-00046 · MDR key 7878668
Device
Generic name
Acne Light Therapy System
Manufacturer
Johnson & Johnson Consumer IncModel number
70501101247Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
28 YR
- Miscarriage
- Miscarriage
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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.