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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-1879

2. Registrant Information.

Registrant Reference Number: 1333419

Registrant Name (Full Legal Name no abbreviations): McLaughlin Gormley King Company

Address: 8810 Tenth Ave North

City: Minneapolis

Prov / State: MN

Country: USA

Postal Code: 55427-4319

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

Domestic Animal

4. Date registrant was first informed of the incident.

14-FEB-14

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

12-FEB-14

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. 1021-1704-85495

Product Name: PetArmor FastAct Flea and Tick Spray for Dogs and Cats

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .957 %
    • PYRETHRINS
      • Guarantee/concentration .188 %
    • PYRIPROXYFEN
      • Guarantee/concentration .125 %

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).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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

DSH

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

15.00

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • 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?

Unknown

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

A report dated 2/14/2014 was forwarded to MGK by the subregistrant for documentation. The report states that caller applied the product to 3 cats 2 days ago. One cat groomed the product off of herself and drooled excessively. She went outside in the morning, and caller left for a couple of hours. Caller found the cat dead when she returned. A second cat also groomed the product off of himself and drooled excessively for an indeterminate amount of time. The third cat has not had any issues. There was not information obtained indicating that any of these cats received an evaluation by a veterinarian. No necropsy was performed on the deceased cat.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the active ingredients used in this product such a causal relationship appears to lack plausibility given the concentrations of the active ingredients within the pet shampoo. The cat's medical history was not obtained, the extent of an existing flea infestation was not documented nor was the application of other flea adulticides ruled out. Furthermore, this cat did not receive a proper veterinary evaluation nor was a necropsy performed to determine the cause of death.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling

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?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Unknown/Inconnu

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

A report dated 2/14/2014 was forwarded to MGK by the subregistrant for documentation. The report states that caller applied the product to 3 cats 2 days ago. One cat groomed the product off of herself and drooled excessively. She went outside in the morning, and caller left for a couple of hours. Caller found the cat dead when she returned. A second cat also groomed the product off of himself and drooled excessively for an indeterminate amount of time. The third cat has not had any issues. There was not information obtained indicating that any of these cats received an evaluation by a veterinarian. No necropsy was performed on the deceased cat.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.