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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7194

2. Registrant Information.

Registrant Reference Number: 130059717

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.

07-MAY-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

05-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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control For Dogs Over 14 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

PMRA Registration No. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea And Tick Control For Dogs Under 14 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 May 4, 2013 the owner applied 1.0 milliliter (mL) of the product for dogs under 14 kilograms (kg) to the dog. On May 5, 2013 the owner applied the same product for dogs over 14 kg to another dog in the home. The smaller dog wrestled with and bit at the larger dog and may have accidentally ingested some of the product that had been applied to the larger dog.

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

Parson Russell Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

21.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Anxiety
    • Symptom - Trembling
    • Symptom - Recumbent
    • Specify - Sternal Recumbency
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Agitation
    • Symptom - Restlessness
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

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

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify Treatment and accidental ingestion of pesticide

17. Provide any additional details about the incident

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

On May 4, 2013 the owner noticed that the dog was symptomatic. Later that evening, the owner noticed additional symptoms. Later that evening, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that mild gastrointestinal (GI) upset or a mild dermal reaction to the product could be seen. During the consultation, the owner stated that the dog was experiencing sternal recumbency, lying upright on his stomach and appearing uncomfortable. The APSS technician recommended that the owner bathe the dog with a liquid dish washing detergent (LDWD), monitor the dog for continued or worsening signs in the 1 to 2 hours following the bath, call back 1 to 2 hours after the bath with the results, take the dog to the veterinarian if the dog's condition worsened in the next 1 to 2 hours, and have the veterinarian call for information.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Later on the evening of May 4, 2013 the owner contacted the APSS to update the case. The owner stated that he did bathe the dog and the dog's anxiety and trembling had become milder; the dog only trembled once since he was bathed. The APSS veterinarian stated that dogs tolerate pyrethroids such as permethrin well and no life-threatening signs would be expected. The APSS veterinarian said that pyrethroids can cause a "pins and needles" sensation (hyperesthesia).The APSS veterinarian recommended that the owner apply a cold compress and call back with questions. On May 5, 2013 the owner noticed that the dog was agitated, restless, and vomiting. The owner bathed the dog with liquid dish washing detergent (LDWD) later that evening. On May 6, 2013 the owner called the APSS to update the case. The owner stated that all of the pet's initial signs had resolved earlier that evening, but the dog had been vomiting. The APSS veterinarian recommended that the owner manage the dog's vomiting by giving nothing by mouth for 1 hour and then slowly reintroducing water and food, feed the dog a bland diet, and call back with questions. At an unknown time, the dog fully recovered. On May 7, 2013 the owner once again contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk with topical products would be for dermal reactions and that permethrins can cause paresthesia or a tingling sensation that some pets find disturbing; they may show agitation or may rub, scratch, or bite at the site of application. The APSS veterinarian also stated that oral ingestion could cause a taste reaction. The APSS veterinarian recommended that the owner prevent further exposure to the product on the larger dog by preventing the dogs from wrestling until the owner had a chance to speak with the product manufacturer.