Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-1994
2. Registrant Information.
Registrant Reference Number: ProPharma Group case:# 1-47620387
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.
28-MAR-17
5. Location of incident.
Country: UNITED STATES
Prov / State: HAWAII
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. 2596-167
Product Name: HARTZ ULTRAGUARD TOPICAL FLEA&TICK PREV. FOR DOGS&PUPPIES 5-14 LBS
- Active Ingredient(s)
- ETOFENPROX
- Guarantee/concentration 55 %
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
- Guarantee/concentration 1 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 10 %
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).
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
Female
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
13
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Blood
- Symptom - Other
- Specify - Internal bleeding
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?
Unknown
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
1-47620387 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal spot-on product containing the active ingredients piperonyl butoxide, etofenprox, and N-octyl bicycloheptene dicarboximide. Four days before the day of initial contact with the registrant, the reporter applied the product to her 13-pound, 11-year-old, female, mixed-breed dog. Approximately 2-3 days later, the dog became lethargic and was urinating blood. The reporter sought veterinary care for the dog where they confirmed anemia, kidney failure and internal bleeding. The dog was treated and discharged, but died at home. The reporter was advised that this is not an expected reaction to the product and necropsy was discussed. No follow-up was attempted. 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