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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-4235
2. Registrant Information.
Registrant Reference Number: Prosar case 1-16245070
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.
06-JUN-085. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
6. Date incident was first observed.
Unknown
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. PMRA Submission No. EPA Registration No. 2596-151
Product Name: UltraGuard Flea and Tick Drops for Dogs and Puppies 4-15 lbs.
- Active Ingredient(s)
- D-PHENOTHRIN
- Guarantee/concentration 85.7 %
- D-PHENOTHRIN
7. b) Type of formulation.
Liquid
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 product had been applied to an 8 week old puppy within 24 hrs of the call. The product was applied against label directions (designed for puppies 12 weeks and under and designed for pets of larger weight).To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Pomeranian
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.17
7. Weight (provide a range if necessary )
2
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Lethargy
- Respiratory System
- Symptom - Difficulty Breathing
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
- General
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
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
1-16245070: The reporter, a veterinarian, called on 6/6/08 to report a topical flea and tick product containing the active ingredient Phenothrin had been applied within the last 24 hours to a puppy that was both too small and too young for the product. According to the reporter, the puppy had presented to his veterinary clinic with vomiting, lethargy, diarrhea, and depressed respirations. The safety profile of the product was discussed, including the fact that some symptoms were inconsistent with the exposure. A recommendation was made to bathe the puppy and to provide symptomatic and supportive care. A follow-up call on 6/9 revealed the puppy belonged to a truck driver who had been passing through town and who had declined hospitalization. The puppy had been bathed several times, had been de-wormed for tapeworms, and had been given injections of an anti-emetic and an antibiotic. She had been discharged on antibiotics and anti-emetics. According to the owner, the puppy had passed away 3 hours after leaving the clinic.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
