Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2009-5257
2. Registrant Information.
Registrant Reference Number: Prosar 1-20474755
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.
20-OCT-09
5. Location of incident.
Country: UNITED STATES
Prov / State: PENNSYLVANIA
6. Date incident was first observed.
17-OCT-09
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. 2596-150
Product Name: UltraGuard Plus Flea/Tick Drops Plus for Dogs/Puppies 31-60 lbs
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 2.3 %
- D-PHENOTHRIN
- Guarantee/concentration 85.7 %
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 was applied to the 65# dog on 10/17/2009. NOTE: The product is labeled for use on dogs weighing 31-60 pounds.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Bloodhound
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.92
7. Weight (provide a range if necessary )
65
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
- Symptom - Loss of appetite
- Renal System
- Symptom - Low urine output
- Specify - Squatting to urinate with very little production
- Symptom - Renal failure
- Symptom - Blood in urine
- Nervous and Muscular Systems
- Symptom - Ataxia
- Specify - "No control over back end"
- Symptom - Seizure
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?
Yes
14. b) How long was the animal hospitalized?
Unknown
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
1-20474755: A reporter (dog owner) called on 10/20/2009 to report the exposure of her dog to a flea and tick product containing the active ingredients Phenothrin and Methoprene. According to the reporter, the product was applied to the dog on 10/17/2009. Within hours following product application, the dog developed vomiting, diarrhea, loss of appetite and lethargy. The dog was also squatting as if attempting to urinate, but only drops of urine were being produced. The reporter was advised that the product has a wide range of safety when used according to label directions. Ingestion of small amount of product via grooming may result in minor, transient gastrointestinal signs such as vomiting or diarrhea. These signs would not be expected to last several days. Urinary or renal signs would not be expected with exposure to the product. A recommendation was made to take the dog to a veterinarian to determine the cause of the signs. On follow up, the reporter stated that the dog was evaluated by a veterinarian and diagnosed with renal failure. On 10/21/2009, the dog had blood in its urine and no control over her back end. The dog had a seizure and died at the veterinary clinic. The reporter was again advised that the product is not expected to result in the extent of signs described. No further information was obtained.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here