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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4421

2. Registrant Information.

Registrant Reference Number: 2013-US-07081

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.

21-MAY-13

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

21-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 for Dogs

  • 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 05/21/2013 at 9:01 PM, NAPCC 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 report, the animal owner applied the collar to the dog on 05/11/2013 at 11:00 AM for the first time for tick prevention. The animal owner also applied one dose of Advantage Multi Imidacloprid Plus Moxidectin for Dogs and Puppies topically to the dog at the same time, per the report.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

7.0

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle weakness
  • Respiratory System
    • Symptom - Coughing
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Cardiovascular System
    • Symptom - Cardiac arrest
  • General
    • Symptom - Death
  • Cardiovascular System
    • Symptom - Heart murmur
    • Symptom - Other
    • Specify - heart attack

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

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 05/21/2013 at 9:01 PM, NAPCC 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 report, the animal owner applied the collar to the dog on 05/11/2013 at 11:00 AM for the first time for tick prevention. The animal owner also applied one dose of Advantage Multi Imidacloprid Plus Moxidectin for Dogs and Puppies topically to the dog at the same time, per the report. The animal owner reported that the dog did not want to eat her dinner at 7:00 PM and was showing signs of ataxia, weakness, and coughing by 8:45 PM. The animal owner also indicated the dog was hypersalivating at the time of the call. NAPCC recommended the animal owner remove the collar and bath the dog with a liquid dish washing detergent to remove the drug products. The animal owner was concerned and was going to take the dog to a veterinarian that evening. On 05/21/2013, at 11:12 PM, the animal owner contacted NAPCC for follow up. Per the report, the animal owner stated that she had taken the dog to a veterinary clinic and the dog had a heart attack and went into cardiac arrest upon arrival to the clinic. The clinic was not able to save her. Apparently the dog had a heart murmur that the animal owner did not know about, per the report. No further information is expected. Note from NAPCC: Because the time course was somewhat consistent, the amount was somewhat consistent, and the findings were poorly consistent, the two drug products were considered to have low likelihood of causing the clinical situation.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Sponsor veterinarian reviewed case and notes that this dog could have had an underlying heart condition that contributed to the sudden decline and subsequent death of this dog. Furthermore, Advantage Multi was used concomitantly with the PREVENTIC collar, so it is unknown what association they had separately or together. Signs would not be expected with the PREVENTIC collar unless the collar was ingested or if the dog had open sores that would have come in contact with the collar, which does not appear to be the case. It is unknown if a necropsy was performed.