New incident report
Incident Report Number: 2018-6141
Registrant Reference Number: 2272874
Registrant Name (Full Legal Name no abbreviations): S.C. Johnson and Son, Limited
Address: 1 Webster Street
City: Brantford
Prov / State: ON
Country: Canada
Postal Code: N3T 5R1
Human
Country: UNITED STATES
Prov / State: MICHIGAN
PMRA Registration No. PMRA Submission No. EPA Registration No. 4822-167
Product Name: OFF! Deep Woods Insect Repellent V 6oz
Yes
Unknown
Site: Personal use / Usage personnel
Data Subject
Sex: Female
Age: >64 yrs / > 64 ans
System
Unknown / Inconnu
Yes
No
Unknown
Non-occupational
Application
What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity
Unknown
Skin
>3 days <=1 wk / >3 jours <=1 sem
>8 hrs <=24 hrs / > 8 h < = 24 h
7/17/2018 Caller applied the product to her lower legs on 7/11/2018 while camping. The next day, she noticed that her legs had dermal irritation, redness, swelling, and were warm to the touch. She washed her legs when she noticed the symptoms. 7/24/2018 Call back to the original caller for follow up. Caller was seen at her primary physician's office on 7/18/2018 where she was advised to go to the emergency room. She had an ultrasound completed on one leg which showed a blood clot. She was prescribed Keflex for cellulitis and started on Eliquis for the blood clot. She told the doctor about product use, and the doctor did not feel her symptoms were related to product use. Blood work was performed at the emergency room, but she is unaware of the results. Her legs are painful and stinging today. She has been elevating her legs at home and using warm and cold compresses. She has a follow up appointment with her physician on 7/26/2018. She has itching from the knee down to the top of her foot. She has been taking Hydroxyzine that was a previously prescribed medication. 7/27/2018 Call back to the original caller for follow up. Caller saw her doctor yesterday, and was told that the product did not have anything to do with her symptoms. She was put on Eliquis to prevent blood clots and Lasix to reduce the swelling in her legs. The doctor said she does not have cellulitis.
Major
Any relationship between the use of this product and the delayed development of the complications reported in this case is inconceivable and lacks biological plausibility. The differential diagnosis for a skin or allergic condition of this nature includes multiple potential etiologies. Targeted allergy testing would be required before concluding that this product may be the causative agent. Additionally a physician who examined here stated that there was no relationship tween her use of the product and the symptoms noted. The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.