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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3250

2. Registrant Information.

Registrant Reference Number: 2013AM155

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

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

Domestic Animal

4. Date registrant was first informed of the incident.

13-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

07-OCT-11

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. 11556 152

Product Name: Advantage II large cat

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.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).

One vial of Advantage II large cat was applied topically by the owner to one spot on the dorsal midline.

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

Unknown

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

13

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Abnormal behaviour
    • Specify - strange
    • Symptom - Hyperactivity
  • Renal System
    • Symptom - Inappropriate urination
    • Symptom - Other
    • Specify - fatty vacuolation of cortical tubules
    • Symptom - Other
    • Specify - acute tubular degeneration in some clusters of tubules (characterised by increased eosinophilia, hyalinity, cytoplasm taking on granular appearance, loss of nuclear detail)
    • Symptom - Other
    • Specify - some tubular lumina contain proteinaceous casts
  • Respiratory System
    • Symptom - Other
    • Specify - vascular congestion
    • Symptom - Other
    • Specify - edema
  • Blood
    • Symptom - Other
    • Specify - large pulmonary artery occluded by organised thrombus
  • Liver
    • Symptom - Other
    • Specify - hepatic parenchyma exhibit acute hepatocellular necrosis

12. How long did the symptoms last?

Unknown / Inconnu

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

Advantage Multi 18 was applied to a 2.5 year old, 13 pound Domestic Shorthair on 4Oct11. This was not the first time application of the product. The cat presented at the veterinary clinic on 7Oct11 for urinating all over the house and acting very hyperactive and "strange." On approximately 9Oct11, the owner found the cat deceased. It should be noted that the cat did have access to the outdoors. A necropsy is pending. 20 Oct 2011: Receipt of technical assessment "The complained batch was manufactured and released according to specification. No deviations occured which lead to the complained AE. " Follow-up, 24Oct11 - The clinic reports they have a low suspcion that the clinical signs were product related. The necropsy results are listed below: General results: Kidney - Fatty vacuolation of the majority of cortical tubules is present. Acute tubular degeneration is observed in some clusters of tubules, characterized by increased eosinophilia, and hyalinity, with cytoplasm taking on a granular appearance and loss of nuclear detail. Tubular lumina occasionally contain proteinaceous casts. Lung - Vascular congestion and edema are pronounced. A large pulmonary artery is occluded by an organized thrombus. Liver - Extensive expanses of hepatic parenchyma exhibit acute hepatocellular necrosis, with preservation of cellular outline, but loss of nuclear and cytoplasmic detail. Histologic diagnosis: Acute tubular nephrosis. Fatty degeneration, kidney. Pulmonary thrombosis. Hepatic infarction. Follow-up, 8 Nov 2011: Further information revealed the involved product was actually Advantage II Large Cat, and not Advocate as originally reported.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Signs and particularly fatal outcome not anticipated with appropriate topical product administration as inconsistent also with Advocate's pharmaco-toxicological profile. Onset time of 3 days not suggestive of product involvement either. Product used before on cat without causing any signs. Sudden death probably not product related but caused by other underlying health problems or intoxication, as cat had access to outside. Technical evaluation not indicative of product involvement. Necropsy results suggested other etiology for death (acute tubular nephrosis, pulmonary thrombosis, heaptic infarction, acute fatty degeneration of kidney). Thus, relation to Advocate which was finally reported as used product unlikely.