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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-2265
2. Registrant Information.
Registrant Reference Number: 2019-CA-000062, 2019-CA-000063, 2019-CA-000064
Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation
Address: 400 Plaza Drive
City: Secaucus
Prov / State: New Jersey
Country: USA
Postal Code: 07094-3688
3. Select the appropriate subform(s) for the incident.
Human
Domestic Animal
4. Date registrant was first informed of the incident.
24-JUN-195. Location of incident.
Country: CANADA
Prov / State: ALBERTA
6. Date incident was first observed.
24-JUN-19Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)PMRA Registration No. 31724 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Rid Flea Dog Shampoo Citrus Scent
- Active Ingredient(s)
- D-PHENOTHRIN
PMRA Registration No. 31724 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Rid Flea Dog Shampoo Fresh Scent
- Active Ingredient(s)
- D-PHENOTHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform II: Human Incident Report (A separate form for each person affected)
1. Source of Report.
Data Subject
2. Demographic information of data subject
Sex: Female
Age: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
- Nervous and Muscular Systems
- Symptom - Dizziness
- General
- Symptom - Other
- Specify - intermittent hot flash feeling
4. How long did the symptoms last?
>2 hrs <=8 hrs / > 2 h < = 8 h
5. Was medical treatment provided? Provide details in question 13.
No
6. a) Was the person hospitalized?
No
6. b) For how long?
7. Exposure scenario
Non-occupational
8. How did exposure occur? (Select all that apply)
Application
9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)
None
10. Route(s) of exposure.
Skin
11. What was the length of exposure?
>15 min <=2 hrs / >15 min <=2 h
12. Time between exposure and onset of symptoms.
>30 min <=2 hrs / >30 min <=2 h
13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)
On 24-Jun-2019, a xyear old, female, human, of unknown weight, in unknown condition, with no known concomitant medical condition, was exposed to an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Citrus Scent (Phenothrin) and also an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Fresh Scent (Phenothrin) while bathing her dogs with the products. The woman wore gloves initially while bathing the dogs the first time, then removed them while bathing the dogs a second time. Approximately 1 hour later, she began to experience an intermittent hot flash feeling, dizziness and then took a shower. The clinical signs resolved approximately three hours later and the woman recovered without medical intervention. Seeking medical attention from a human physician was recommended if the clinical signs returned or if any new clinical signs developed. No further information was received in this case.
To be determined by Registrant
14. Severity classification.
Minor
15. Provide supplemental information here.
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 cannot 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.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Border collie
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
25
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- General
- Symptom - Lethargy
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On 24-Jun-2019, a 1 year old, 25 pound, intact, female, Border collie in unknown condition, with concomitant medical condition of itching, was administered an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Citrus Scent (Phenothrin) and also an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Fresh Scent (Phenothrin) via the topical route by the animal owner. The shampoo was left on the dog for five minutes prior to rinsing. Approximately one hour after product use the dog developed lethargy. Bathing the dog with liquid dish detergent to remove the product and continuing to monitor the clinical sign was recommended. Veterinary evaluation was also recommended if the clinical sign persisted or worsened. The dog had not been evaluated by a veterinarian, no treatment had been performed and the clinical sign continued. No further information was received in this case.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
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 cannot 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.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Border collie
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
30
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>15 min <=2 hrs / >15 min <=2 h
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Shaking
- General
- Symptom - Lethargy
- Skin
- Symptom - Other
- Specify - skin felt hot
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On 24-Jun-2019, an 8 year old, 30 pound, intact, female, Border collie in unknown condition, with concomitant medical conditions of pruritus, red skin and multiple hotspots, was administered an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Citrus Scent (Phenothrin) and also an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Fresh Scent (Phenothrin) via the topical route by the animal owner. The shampoo was left on the dog for ten minutes prior to rinsing. The products were used off label as they are not intended for use on dogs with broken skin. Approximately one minute post bathing, the dog developed shaking, lethargy, and its skin felt hot to the touch. The owner then bathed the dog with liquid dish soap. Bathing the dog a second time with liquid dish soap was recommended. Veterinary evaluation was recommended if the clinical signs persisted or worsened. The dog had not been evaluated by a veterinarian, no treatment had been performed and the clinical signs continued. No further information was received in this case.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Assessment: The active ingredient, phenothrin, is present in low concentration in this product and has a wide margin of safety in dogs. The rapid onset shaking, lethargy and warm skin may have been related to a paresthesia response. Systemic effects are not expected. The dog also had areas of damaged skin (hot spots) when the product was applied. This may have also contributed to the reported signs if the product entered those areas of broken skin causing irritation. 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 cannot 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.
