Incident Report
Subform I: General Information
1. Report Type.
Update the report
Incident Report Number: 2015-2303
2. Registrant Information.
Registrant Reference Number: 2015-US-05132
Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)
Address: 16750 Transcanada Highway
City: Kirkland
Prov / State: Quebec
Country: Canada
Postal Code: H9H 4M7
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
18-MAY-15
5. Location of incident.
Country: UNITED STATES
Prov / State: GEORGIA
6. Date incident was first observed.
17-MAY-15
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. 773-95
Product Name: ACTIVYL TICK PLUS
- Active Ingredient(s)
- INDOXACARB TECHNICAL
- PERMETHRIN
- Guarantee/concentration 42.5 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
2
Units: mL
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).
Suspected adverse reaction: On 18 May 2015, an owner reported that her dog who had been dosed with Activyl Tick Plus Spot-On for Dogs and Puppies (over 22 lb and up to 44 lb) on 01 May 2015 died suddenly on 17 May 2015. The dog had a history of coughing. A littermate who was also dosed with Activyl Tick Plus (17 Apr 0215) died 18 May 2015 (2015-US-05137). Both dogs were outdoor dogs. The product was purchased from a vet clinic. Necropsies were pending. Further information expected.
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 Breed
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
14.0
7. Weight (provide a range if necessary )
35.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
<=15 min / <=15 min
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
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
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Status update August 4 2015: 28 Jul 2015 Follow Up: Necropsy results: Findings indicate the dog died from Heartworm disease. A splenic mass with metastasis to the liver was also noted. No further information expected.