Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-5631
2. Registrant Information.
Registrant Reference Number: ProPharma Group case:# 1-45404765
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.
29-AUG-16
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
29-AUG-16
Product 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. 31007
PMRA Submission No.
EPA Registration No.
Product Name: HARTZ ULTRAGUARD PLUS FLEA & TICK TREATMENT FOR DOGS AND PUPPIES WEIGH
- 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).
1-45404765 - The product is intended for a 6-14 kilogram dog. The reporter applied one-half of a tube of the product to a 4.55 kilogram dog. The reporter also stated she had used a non-company flea and tick indoor treatment with unknown active ingredients at an unknown time.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Mixed Breed
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
4.55
kg
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
- Gastrointestinal System
- Symptom - Inappropriate defecation
- Nervous and Muscular Systems
- Symptom - Difficulty getting up
- General
- Symptom - Hypothermia
- Symptom - Death
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
1
Day(s) / Jour(s)
15. Outcome of the incident
Died
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
1-45404765- The reporter, a pet owner, indicated her dog was exposed to an insecticidal spot-on product containing the active ingredients (S)-methoprene and D-phenothrin. Two days before the day of initial contact with the registrant, the reporter applied the product to her 4.55-kilogram, 7-year-old, male, mixed breed dog. On the day of initial contact, the reporter woke to find the dog lethargic, not wanting to get up, having seizures, uncontrolled defecation, and his body felt cold. The reporter took the dog to the veterinarian where he was placed on intravenous fluids and medication. One day after initial contact, the reporter called to say she had taken the dog home the day before as he seemed to be doing better. During the night the dog started having a seizures and died. Condolences were offered and the reporter requested information for the necropsy procedure. No additional information is available.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here