Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-7267
2. Registrant Information.
Registrant Reference Number: ProPharma Group case:# 1-46067461
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.
27-OCT-16
5. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
6. Date incident was first observed.
27-OCT-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.
PMRA Submission No.
EPA Registration No. 2596-153
Product Name: HARTZ ULTRAGUARD RID FLEA & TICK DOG SHAMPOO
- Active Ingredient(s)
- D-PHENOTHRIN
- Guarantee/concentration .27 %
7. b) Type of formulation.
Liquid
Other (specify)
Shampoo
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).
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
Maltese
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 )
5.5
lbs
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Nervous and Muscular Systems
- Gastrointestinal System
- Symptom - Salivating excessively
- Nervous and Muscular Systems
- Symptom - Muscle tremors
- Symptom - Ataxia
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
1-46067461 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal shampoo containing the active ingredient D-phenothrin. One day before the day of initial contact with the registrant, the reporter bathed her 5.5-pound, 11-month-old, female Maltese dog with the product. During the bathing, the dog licked the water and immediately vomited. Within 45 minutes after bathing, the dog had ataxia, hyper-salivation and muscle tremors. The reporter bathed the dog again with an unknown shampoo and brought her to a veterinarian. The dog died after being at the veterinary clinic for 5 minutes. The reporter was told that this is not an expected reaction to the product. Necropsy was discussed with the reporter and the proper forms were faxed to the veterinary clinic. 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