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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2015-7056

2. Registrant Information.

Registrant Reference Number: 2015-US-14167

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.

13-NOV-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

09-NOV-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).

Treatment given;Bathed,Carprofen,Joint upplement, Methocarbamol,Gabapentin, Phenobarbitol, Valium.Suspected Adverse Reaction: On 13 Nov 2015 a veterinarian called to report a possible reaction in an 8 year old, female spayed Boston Terrier dog weighing 22pounds. Limited information was available for this case.The dog presented to the clinic for fleas and had Activyl applied. The veterinarian was not sure if Activyl or Activyl Tick Plus was applied, if the product was applied on 02 or 03 Nov or what size product was used.The dog was kept in the hospital overnight. The owner reported that the dog had a seizure on 05 Nov 2015 and became paralyzed in the rear limbs on 09 Nov 2015.On 16 Nov 2015 the vet reported that on 14 Nov 2015 the dog was taken to the hospital and was noted to be paralyzed in the rear limbs with intact sensory reflexes. A chemistry panel revealed a mildly elevated ALT of 138(12-118-units not given)and a mildly elevated amylase of 283 (units not given but low end of normal was mentioned as 280).The dog was treated with Methocarbamol.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Boston Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

22.00

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Trembling
    • Symptom - Other
    • Specify - Hyporeflexia
    • Symptom - Other
    • Specify - Impaired proprioception
    • Symptom - Other
    • Specify - Status Epilepticus
  • Gastrointestinal System
    • Symptom - Anorexia
  • Respiratory System
    • Symptom - Panting
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • Liver
    • Symptom - Elevated liver enzymes
  • Blood
    • Symptom -
    • Specify - Elevated Amylase
  • Nervous and Muscular Systems
    • 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?

24

Hour(s) / Heure(s)

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

On 15 Nov 2015 the dog had two seizures and another was reported on 16 Nov 2015.Additional information expected.Follow-up on 23 Nov 2015:the vet was contacted and read the medical records for clarification: the dog had originally presented on 03 Nov 2015 to the clinic for fleas, purulent discharge from the vulva,blindness, lethargy, hind limb weakness and had no pupillary light reflexes or menace reflexes and was diagnosed with rear limb arthritis.The dog was started on amoxicillin. On 04 Nov 2015 the dog was treated with Activyl Tick Plus and was discharged from the hospital. On 05 Nov 2015 the dog was dispensed carprofen and a joint supplement.On 09 Nov 2015 the owner reported the dog's hind legs were trembling when asleep.On 10 Nov 2015 the owner called and reported she thought the dog had a seizure.On 12 Nov 2015 the owner called and reported the dog was panting and was restless at night.On 14 Nov 2015 the dog continued having seizures, was bathed twice, was seen at the clinic, bloodwork previously noted was performed and the dog was started on Methocarbamol.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

. On 17 Nov 2015 the seizures were increasing in frequency and the dog was started on Gabapentin. On 23 Nov 2015 the seizures were increasing in frequency and duration(4 -5 seizures a day,20 minutes in duration).On 24 Nov 2015 the dog presented to the clinic and was anorexic,had no placing reflex of the forelimbs(coded as reduced reflexes),but would place the hind limbs, crossed the forepaws when standing(coded as impaired proprioception), and no longer had tremoring.The dog was able to stand but the legs would buckle when attempting to walk.The vet does not believe the signs are related to Activyl.The dog was started on phenobarbitol on 24 Nov 2015.On 27 Nov 2015 the vet contacted the Animal Product Safety Service and reported that the dog had gone into status seizuring on 26 Nov 2015. Valium was added to the treatment protocol. On 30 Nov 2015 the vet contacted MAH and reported that on 30 Nov 2015 the dog died.The vet was not sure if the owner would do a necropsy.The vet believed the dog had an intracranial cause for the seizures.No additional information expected.