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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-2282
2. Registrant Information.
Registrant Reference Number: 2019-CA-000112 and 2019-CA-000113 (linked cases)
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.
Domestic Animal
4. Date registrant was first informed of the incident.
24-SEP-195. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
03-JUL-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. 30730 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Pro Drops for Dogs 14 - 28 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- D-PHENOTHRIN
PMRA Registration No. 25382 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Plus Flea and Tick Collar for Dogs and Puppies
- Active Ingredient(s)
- (S)-METHOPRENE
- TETRACHLORVINPHOS
PMRA Registration No. 30731 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Pro Drops for Dogs Over 28 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- 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?
YesSubform 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
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
46
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Seizure
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 approximately 01-Jul-2019, a 5 year old, 46 pound, neutered, male, Border Collie dog, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Hartz UltraGuard Pro Drops for Dogs 14 - 28 kg (Phenothrin / S Methoprene) via the topical route by the animal owner. On approximately 02-Jul-2019, the dog exhibited what the animal owner believes to be two seizures. The first seizure was not witnessed but a loud noise was heard. After the animal owner witnessed the dog's seizure, they bathed the dog with liquid dish soap multiple times for product removal. On approximately 28-Aug-2019, the dog was administered 1 collar of Hartz UltraGuard Plus Flea and Tick Collar for Dogs and Puppies (Tetrachlorvinphos / S Methoprene) via the topical route by the animal owner. On approximately 23-Sep-2019, the dog exhibited another seizure. The collar was removed and the application site was washed with liquid dish soap. The dog had not been evaluated by a veterinarian and no treatment had been performed. Veterinary evaluation was recommended to rule out other potential causes for the seizures. 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: Seizures are not anticipated following use of either product. Both are considered to have a wide margin of safety in dogs and have poor systemic absorption across intact skin. The development of a seizure several weeks after application of the collar is especially indicative that other causes are more likely including idiopathic epilepsy considering the age and breed of the dog. 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.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Siberian Husky/ Labrador Retriever
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
110
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Hair loss
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 approximately 01-Jul-2019, a 5 year old, 110 pound, neutered, male, Siberian Husky/Labrador Retriever crossbred dog, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Hartz UltraGuard Pro Drops for Dogs Over 28 kg (Phenothrin / S Methoprene) via the topical route by the animal owner. On approximately 28-Aug-2019, the dog was administered 1 collar of Hartz UltraGuard Plus Flea and Tick Collar for Dogs and Puppies (Tetrachlorvinphos / S Methoprene) via the topical route by the animal owner. On approximately 31-Aug-2019, the dog developed application site pruritus and the fit of the collar was adjusted by the animal owner. On approximately 11-Sep-2019, the collar was removed and hair thinning at the application site was observed. The application site was washed with liquid dish soap by the animal owner. 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 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.
