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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-3141
2. Registrant Information.
Registrant Reference Number: 2013-US-04038
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.
23-MAY-135. Location of incident.
Country: UNITED STATES
Prov / State: NEW YORK
6. Date incident was first observed.
17-MAY-13Product 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.
4Units: 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 Lack of Expected Efficacy. On 23 May 2013 a vet reported that a dog that had been previously treated with Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb) had developed Lyme disease. The dog was treated with Activyl Tick Plus on 29 Apr 2013 by the owner. The product was purchased at the veterinary clinic. The previous ectoparasiticide was not a MAH product. On 17 May 2013 the dog presented to the vet clinic with weight loss of an unspecified duration and 3+ protein in its urine. The dog tested positive for Lyme disease on the AccuPlex Plus 4 test. A previous negative Lyme test was not reported. The veterinarian did not know if the dog had ever received a Lyme vaccine. The dog is currently under treatment. The Quant C6 results ( 10/ml) are not indicative of active Lyme disease. In a follow up conversation on 31 May 2013, the vet reported that the dog was lethargic and anorexic on 27 May 2013. The dog was examined by the vet on 28 May 2013 and was diagnosed with a splenic hemangiosarcoma. The dog was euthanized that day. No more information expected.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Labrador Retriever cross with unknown canine breed
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
13.00
7. Weight (provide a range if necessary )
59.0
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
- Gastrointestinal System
- Symptom - Weight loss
- Renal System
- Symptom - Proteinuria
- General
- Symptom - Lethargy
- Gastrointestinal System
- Symptom - Anorexia
- General
- Symptom - Cancer
- Specify - splenic hemangiosarcoma
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
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
Euthanised / Euthanasie
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
Suspected Lack of Expected Efficacy. On 23 May 2013 a vet reported that a dog that had been previously treated with Activyl Tick Plus for Dogs and Puppies (over 44 lb and up to 88 lb) had developed Lyme disease. The dog was treated with Activyl Tick Plus on 29 Apr 2013 by the owner. The product was purchased at the veterinary clinic. The previous ectoparasiticide was not a MAH product. On 17 May 2013 the dog presented to the vet clinic with weight loss of an unspecified duration and 3+ protein in its urine. The dog tested positive for Lyme disease on the AccuPlex Plus 4 test. A previous negative Lyme test was not reported. The veterinarian did not know if the dog had ever received a Lyme vaccine. The dog is currently under treatment. The Quant C6 results ( 10/ml) are not indicative of active Lyme disease. In a follow up conversation on 31 May 2013, the vet reported that the dog was lethargic and anorexic on 27 May 2013. The dog was examined by the vet on 28 May 2013 and was diagnosed with a splenic hemangiosarcoma. The dog was euthanized that day. No more information expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
