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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0790

2. Registrant Information.

Registrant Reference Number: 130138174

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.

02-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

Unknown

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. 2724-504-270

Product Name: Adams Spot On Flea And Tick Control For Cats 5 Lbs And Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

Units: mL

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 August 17, 2013 the owner applied the product to 3 cats to treat for fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

17.0

7. Weight (provide a range if necessary )

13.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Renal System
    • Symptom - Urinary incontinence
  • Gastrointestinal System
    • Symptom - Anorexia
  • Renal System
    • Symptom - Urine discoloration
  • 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?

Unknown

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

Between August 24, 2013 and August 30, 2013 the owner noticed that the cat had moderate urinary incontinence. Between August 30, 2013 and September 1, 2013 the owner took the cat to the veterinarian, where Amoxicillin was given to the cat. Between August 31, 2013 and September 6, 2013 the owner noticed that the cat's urinary incontinence had improved somewhat, but the cat was anorexic. Between September 3, 2013 and September 7, 2013 the owner noticed that the cat's urinary incontinence was severe. Between September 5, 2013 and September 7, 2013 the owner noticed that the cat had discolored urine that was mild pink in color. On September 7, 2013 the owner observed that the cat had died. On October 2, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Etofenprox is classified as both a pyrethroid-like insecticide and a non-ester pyrethroid, and it is safe to use on cats and dogs; it does not result in tremors or seizure activity that can be seen with other pyrethroids since it is structurally different. The APSS veterinarian stated that oral exposures often result in hypersalivation, nausea, and possibly hiding because of the bad taste, and some animals will hypersalivate just from the odor of the product. The APSS veterinarian said that the cat could have possibly had renal failure or pyelonephritis, given her previous history. A necropsy was not available.


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 and that renal failure was considered to have a medium likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Hiding
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • 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?

Treatment / Traitement

17. Provide any additional details about the incident

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

Between August 29, 2013 and September 4, 2013 the owner noticed that the cat was hiding and anorexic. On September 9, 2013 the owner observed that the cat had died. On October 2, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Etofenprox is classified as both a pyrethroid-like insecticide and a non-ester pyrethroid, and it is safe to use on cats and dogs; it does not result in tremors or seizure activity that can be seen with other pyrethroids since it is structurally different. The APSS veterinarian stated that oral exposures often result in hypersalivation, nausea, and possibly hiding because of the bad taste, and some animals will hypersalivate just from the odor of the product. The APSS veterinarian said that she suspected that the cat died from flea anemia. A necropsy was not available.


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 and that anemia was considered to have a medium likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

13.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
  • General
    • Symptom - Abnormal behaviour
    • Specify - Anti Social Behavior
    • 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?

Treatment / Traitement

17. Provide any additional details about the incident

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

Between August 30, 2013 and September 1, 2013 the owner noticed that the cat had alopecia at the back of the neck where the product had been applied and was exhibiting anti-social behavior, hiding in the bathroom and only coming out to eat. On September 24, 2013 the cat died while unattended. On October 2, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Etofenprox is classified as both a pyrethroid-like insecticide and a non-ester pyrethroid, and it is safe to use on cats and dogs; it does not result in tremors or seizure activity that can be seen with other pyrethroids since it is structurally different. The APSS veterinarian also stated that dermal exposures may cause mild dermal irritation and hyperesthesia, and possibly secondary alopecia from pruritus. The APSS veterinarian said that she suspected that the cat died from flea anemia. A necropsy was not available.


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 and that anemia was considered to have a medium likelihood of causing the clinical situation.