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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-4182
2. Registrant Information.
Registrant Reference Number: Prosar case 1-16386853
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.
11-JUL-085. Location of incident.
Country: UNITED STATES
Prov / State: NEW YORK
6. Date incident was first observed.
07-JUL-08Product 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.
Product Name: UltraGuard Flea and Tick Drops for Dogs and Puppies Over 60 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 reporter applied the product to her dog on 7/6/08.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform II: Human Incident Report (A separate form for each person affected)
1. Source of Report.
Other
2. Demographic information of data subject
Sex: Male
Age: >6 <=12 yrs / > 6 < = 12 ans
3. List all symptoms, using the selections below.
System
- General
- Symptom - Lethargy
- Nervous and Muscular Systems
- Symptom - Headache
4. How long did the symptoms last?
Unknown / Inconnu
5. Was medical treatment provided? Provide details in question 13.
Unknown
6. a) Was the person hospitalized?
Unknown
6. b) For how long?
7. Exposure scenario
Unknown
8. How did exposure occur? (Select all that apply)
Other
9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)
10. Route(s) of exposure.
Unknown
11. What was the length of exposure?
Unknown / Inconnu
12. Time between exposure and onset of symptoms.
Unknown / Inconnu
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.)
1-16396853: The reporter called on 7/11/08 to report the death of her 10 year old male dog after the application of a topical flea and tick product containing the active ingredient Phenothrin. According to the reporter, she had applied the product on 7/6. The next day, the dog had been seen scratching at itself. On 7/9, the dog had been observed shaking in his sleep. On 7/10, the dog had been lying down and then had vomited 2 times. The dog had passed away suddenly about 1-2 hours later. The reporter stated that this had occurred while they had been at a cabin in the mountains; it was not known if the dog had ingested something outside or something in the cabin. Per the reporter, her (age) year old son had developed a headache and lethargy at some point as well. The reporter was uncertain whether he was ill or depressed about the dog¿s death. For the dog - the safety profile of the product was discussed, including the potential for a paraesthesia type of effect. It was also discussed that any reaction to the product would typically be expected to develop within 24 hrs after application. For the son ¿ it was discussed that the symptoms described by the reporter would not be expected from touching or petting the dog. No additional information is available.
To be determined by Registrant
14. Severity classification.
Minor
15. Provide supplemental information here.
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 )
10
7. Weight (provide a range if necessary )
68
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Itchy skin
- Nervous and Muscular Systems
- Symptom - Shaking
- Specify - Shaking in his sleep
- Gastrointestinal System
- Symptom - Vomiting
- General
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
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
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
1-16386853: The reporter called on 7/11/08 to report the death of her 10 year old male dog after the application of a topical flea and tick product containing the active ingredient Phenothrin. According to the reporter, she had applied the product on 7/6. The next day, the dog had been seen scratching at itself. On 7/9, the dog had been observed shaking in his sleep. On 7/10, the dog had been lying down and then had vomited 2 times. The dog had passed away suddenly about 1-2 hours later. The reporter stated that this had occurred while they had been at a cabin in the mountains; it was not known if the dog had ingested something outside or something in the cabin. Per the reporter, her 11 year old son had developed a headache and lethargy at some point as well. The reporter was uncertain whether he was ill or depressed about the dog¿s death. For the dog - the safety profile of the product was discussed, including the potential for a paraesthesia type of effect. It was also discussed that any reaction to the product would typically be expected to develop within 24 hrs after application. For the son ¿ it was discussed that the symptoms described by the reporter would not be expected from touching or petting the dog. No additional information is available.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
