Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-4191
2. Registrant Information.
Registrant Reference Number: Prosar case 1-16368668
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.
07-JUL-08
5. Location of incident.
Country: CANADA
Prov / State: SASKATCHEWAN
6. Date incident was first observed.
27-JUN-08
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. 26489
PMRA Submission No.
EPA Registration No.
Product Name: Control Pet Care System One Spot for Dogs and Puppies 14 kg and Under
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
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).
The reporter applied the product to the dog on 6/26/08.
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
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2.5
7. Weight (provide a range if necessary )
20
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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?
5
Day(s) / Jour(s)
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
1-16368668: The reporter called on 7/7/08 to report the application of a topical flea and tick product containing the active ingredients Permethrin and Methoprene to her 2.5 year old dog 12 days earlier (6/26). According to the reporter, the dog had developed seizures on 6/27/08 about 15 hrs after product application. The dog had a total of 4 seizures in 24 hours, and was evaluated by a veterinarian on 6/28. Per the reporter, the dog was monitored at the veterinary clinic for 5 days. By the time of the call, the dog had become asymptomatic but remained on Phenobarbital. The reporter requested and was given information regarding the company case review and reimbursement process. No additional information is available.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here