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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3241

2. Registrant Information.

Registrant Reference Number: 2013AM146

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.

19-AUG-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. Unknown

Product Name: Advantage II

  • 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.

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).

One vial of Advantage II 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

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Confusion
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Renal System
    • Symptom - Lack of control of urination
    • Specify - soiled himself
  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Edema
  • Blood
    • Symptom - Anemia
  • Cardiovascular System
    • Symptom - Other
    • Specify - myocarditis
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Listless
  • Eye
    • Symptom - Contraction of the pupil
  • Nervous and Muscular Systems
    • Symptom - Coma

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

8/19/2011 12:34:25 PM Caller states that she applied the product 2 days ago and within 2 hrs, the cat developed ataxia and confusion. He stopped eating and drinking and soiled himself. The cat is being tx at the Vet currently and the Vet has made a statement that the rxn is directly related to the product. Caller is a Nurse Practitioner and does research for pharmaceuticals. Caller states that the cat is going to die and that the death is directly attributed to the product. 8/19/2011 12:48:27 PM: Owner did not have a UPC or EPA, gave the CVT the name and the lot number. Packaging is at the DVM. O purchased the product from (name)t. Owner noticed some lethargy 2 hours after the application. The caller applied the product late in the evening and in the a.m. the pet didn't eat or drink much. The owner then used a medicine dropper to force fluids. That evening the pet was increasingly listless and started vomiting. The package is at the DVM office. Per the owner the DVM indicated that he could not save the pet and that the product had poisoned him. She is calling to report the adverse event and is asking for financial reimbursement for medical expenses. Client wants financial reimbursement for medical care. 8/23/11 - The veterinarian said that the cat came in first thing in the morning on 8/19/11. The cat was in a coma and the cat had constriction of the pupils. The cat was treated with intravenous fluids, atropine every four hours and hyperbag oxygen. 10 hours later the cat passed away. The cat has an unknowm medical history and this was the first time the kitten was seen by the veterinarian. The body will be sent in for a necropsy. Update 14.10.2011 Technical assessment: The batch was manufactured according to specification. No deviations that could have led to the complained adverse event occurred. The certificate of analysis is attached to the complaint. Since no complaint sample is available, we cannot perform further investigations. Update 20.10.2011 The necropsy was done on 8/31/11. The necropsy results show pulmonary congestion and edema, mild anemia and intestinal parasitism (roundworms 4+) with a mucoid bloody digesta. Histopathology findings were multifocal chronic suppurative myocarditis, pulmonary edema and parasitic enteritis. No further information is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reported signs are not anticipated with appropriate topical product use as inconsistent with pharmaco-toxicological product profile. Though initial lethargy may be a possible side effect, aggravation of signs not anticipated with product use. A necropsy examination revealed pulmonary congestion and edema, mild anemia and myocarditis suggestive of aberrant Toxoplasma migration. The technical revision of the complained batch did not reveal any deviation from the specification. All things considered is a product relation unlikely.