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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4422

2. Registrant Information.

Registrant Reference Number: 2013-US-07723

Registrant Name (Full Legal Name no abbreviations): Virbac Animal Health

Address: 3200 Meacham Blvd.

City: Fort Worth

Prov / State: TX

Country: United States

Postal Code: 76137

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

04-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

18-MAY-13

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. 2382-104

Product Name: Preventic Collar for Dogs 18"

  • Active Ingredient(s)
    • AMITRAZ
      • Guarantee/concentration 9 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Advantage Multi to the dog

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: Collar

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).

On 06/04/2013, sponsor was contacted by the animal owner to report an apparent adverse reaction to the PREVENTIC (18/9% Amitraz) Tick Collar for Dogs. On 05/06/2013 the animal owner applied Advantage Multi to the dog and then on 05/17/2013 the animal owner applied the PREVENTIC collar to the dog for the first time.

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

Schnauzer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

22.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Trembling
  • General
    • Symptom - Pain
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Death

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

On 06/04/2013, sponsor was contacted by the animal owner to report an apparent adverse reaction to the PREVENTIC (18/9% Amitraz) Tick Collar for Dogs. According to the attending veterinarian, the dog was seen at the clinic on 04/11/2013 for an annual exam and vaccinations (Rabies, DHLPP). The dog tested positive for Lyme Disease and was started on unspecified doses of Minocycline and administered a Lyme vaccine at that time. On 04/19/2013 the dog presented to the clinic lethargic, depressed, not eating, and had a painful abdomen. The dog tested positive for Pancreatitis and had a barium series performed, as there was some concern of a foreign body. The dog fully recovered and was discharged forty-eighty hours later. On 05/05/2013 the dog returned to the clinic for Lyme and Distemper booster vaccines. The dog was playful at that time, but hesitant to jump up, per the veterinarian. At this time the animal owner purchased the PREVENTIC collar from the clinic. On 05/06/2013 the animal owner applied Advantage Multi to the dog and then on 05/17/2013 the animal owner applied the PREVENTIC collar to the dog for the first time. Approximately twenty-four hours later, the dog became lethargic, could not jump, and was trembling in the rear legs, per the veterinarian. On 05/18/2013 the collar was removed, the dog was bathed, and the dog was seen at the clinic. The clinic performed blood work and the dog's PCV was 36 percent and the dog had a mildly elevated ALT and ALKP. The dog was sent home with unspecified doses of Amoxicillin and pain medication (unspecified NSAID). On 05/20/2013 the dog returned to the clinic with neck pain, trembling, and inappetence. The clinic performed an ACTH stem test which came back inconclusive. The dog was sent home and the animal owner called the clinic to report the dog passed away on 05/21/2013. The veterinarian did not feel the adverse event was related to the PREVENTIC; however, she did promise the animal owner that she would contact all the companies (i.e. vaccines, topicals, oral drugs, etc...) to see if this could be an expected reaction to any of the drug products. The veterinarian indicated that the dog was seen at the clinic back in September 2012 and she had suspected the dog had Lyme disease at that time. No further information is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Sponsor notes that it is unlikely that the PREVENTIC collar can be associated with the dog's clinical signs and subsequent death, and it is more likely related to complications with the Lyme disease. The attending veterinarian did not think the adverse event was related to the PREVENTIC collar.