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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5170

2. Registrant Information.

Registrant Reference Number: 160079720

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.

03-JUN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

20-MAY-16

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. 2724-803-270

Product Name: Adams Flea and Tick Spray for Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • ETOFENPROX
      • Guarantee/concentration .25 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .75 %

7. b) Type of formulation.

Liquid

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 20, 2016 the owner sprayed the product onto the first cat to treat for fleas. On June 1, 2016 the owner sprayed the product onto the second cat to treat for fleas. After the second cat became symptomatic and was bathed, the owner reapplied the product onto the second cat on June 2, 2016.

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

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
    • Symptom - Vomiting
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

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 May 20, 2016, shortly after the product was applied, the cat developed hypersalivation. On May 21, 2016 the cat started vomiting. On May 22, 2016 the cat died. On June 3, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated can see drooling, retching from the scent; heavy application may cause depression, ataxia. The APSS veterinarian also stated excessive grooming of agent may also cause vomiting. The APSS veterinarian further stated active ingredient concentration is low so would not expect agitation. The APSS veterinarian finally stated severe signs would not be expected. The APSS veterinarian recommended a necropsy. The owner stated he didn't have a regular vet, but would consider the necropsy.


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 considered to have a doubtful likelihood of causing the clinical situation. On June 4, 2016 the owner contacted the APSS to state he wanted a necropsy. The APSS veterinarian discussed that he needed to call a veterinarian to work with. On June 7, 2016 an APSS technician called the owner to state that this would be the last day that the owner could send the pet out for a necropsy. The APSS technician was unable to leave a message, so attempted later that day but had the same outcome. On June 10, 2016 the owner contacted the APSS and stated he had contacted 3 vets and they were unable to submit a necropsy, so he buried the cat's body.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

6.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • Respiratory System
    • Symptom - Coughing
    • Symptom - Sneezing
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Weakness
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Recumbent
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

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 June 1, 2016 shortly after the product was applied the cat developed hypersalivation and isolated events of coughing and sneezing. On June 2, 2016 the cat developed inappetence, weakness, and ataxia. The owner then bathed the cat (with liquid dish washing detergent (LDWD) and aloe shampoo). The owner then reapplied the product onto the cat. The cat then became recumbent, developed vocalization, and became unresponsive. On June 3, 2016 the owner found the cat had died. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated can see drooling, retching from the scent; heavy application may cause depression, ataxia. The APSS veterinarian also stated excessive grooming of agent may also cause vomiting. The APSS veterinarian further stated active ingredient concentration is low so would not expect agitation. The APSS veterinarian finally stated severe signs would not be expected. The APSS veterinarian recommended a necropsy. The owner stated he didn't have a regular vet, but would consider it.


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 considered to have a doubtful likelihood of causing the clinical situation. On June 4, 2016 the owner contacted the APSS to state he wanted a necropsy. The APSS veterinarian discussed that he needed to call a veterinarian to work with. On June 7, 2016 an APSS technician called the owner to state that this would be the last day that the owner could send the pet out for a necropsy. The APSS technician was unable to leave a message, so attempted later that day but had the same outcome. On June 10, 2016 the owner contacted the APSS and stated he had contacted 3 vets and they were unable to submit a necropsy, so he buried the cat's body.