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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2843

2. Registrant Information.

Registrant Reference Number: 120177241

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

25-DEC-12

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

24-DEC-12

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. 2724-811-270

Product Name: Adams Flea And Tick Spot On For Dogs For Use Only On Extra Large Dogs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 30 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.23

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Subdued
  • Gastrointestinal System
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Depression
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Parvovirus infection
    • Symptom - Death

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On December 24, 2012, sometime after the puppy may have accidentally ingested some of the product, the owner noticed that the puppy was subdued and later started having diarrhea. On December 25, 2012 the owner noticed that the puppy was depressed and anorexic. A short time later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that if the puppy had chewed on the applicator the day before and had ingested a drop or 2 of residue, drooling and/or a bad taste reaction would have been expected. The APSS veterinarian also stated that the puppy's signs were not consistent with an oral exposure to the product and suspected that the puppy might have parvovirus. The APSS veterinarian recommended that the owner isolate the puppy from the other 2 puppies in the house and wipe up any accident sites with a bleach and water solution, take the puppy to the veterinarian that day if possible and especially if the puppy became more depressed or started to vomit, call back with questions, and have her veterinarian call for information.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On December 27, 2012 an APSS assistant called the owner to update the case. The owner stated that she took the puppy to the clinic on December 26, 2012 and that the puppy tested positive for parvovirus. The owner also stated that the dog had died on the morning of December 27, 2012. The APSS veterinarian stated that that parvovirus was considered to have a high likelihood of causing the clinical situation. A necropsy was not available.