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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3243

2. Registrant Information.

Registrant Reference Number: 2013AM148

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-SEP-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

Ragdoll

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

3

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Anxiety
  • Respiratory System
    • Symptom - Respiratory distress
  • Gastrointestinal System
    • Symptom - Foaming at mouth
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Respiratory System
    • Symptom - Mouth breathing
  • Cardiovascular System
    • Symptom - Cardiac arrest
  • Gastrointestinal System
    • Symptom - Vomiting
  • Skin
    • Symptom - Cyanosis
  • Cardiovascular System
    • Symptom - Other
    • Specify - small heart size
  • General
    • Symptom - Fever
  • Respiratory System
    • Symptom - Pulmonary edema
    • Specify - diffusely hemorrhagic
    • Symptom - Other
    • Specify - significant numbers of eosinophils in alveolar fluid
  • Gastrointestinal System
    • Symptom - Other
    • Specify - bloody effusion in abdomen and chest
    • Symptom - Other
    • Specify - petechiae on omentum
  • General
    • Symptom - Other
    • Specify - mesenteric nodes slightly prominent
  • Renal System
    • Symptom - Other
    • Specify - mild to moderate medullary fibrosis
    • Symptom - Other
    • Specify - tubular degeneration

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?

Yes

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

9/19/2011 1:43:32 PM: DVM states Advantage II was applied for the first time on 9/15/11 in the clinic at the time of an appointment for dysuria. The cysto was not submitted. The cat was discharged and became distressed on the car ride home and developed respiratory distress. The cat re-presented immediately upon arriving home and re-presented cyantoic, open mouth breathing, foaming, salivating and recumbent. The cat was intubated and was placed on O2, had a temperature of 103.6. The cat arrested within 10 minutes, and was re-vived with CPR, then arrested again within 3 minutes and the caller states they were unable to revive the cat a second time. The caller states a necropsy was performed and the DVM cannot tell what was post mortem change, but states she sees bloody fluid in the chest and abdomen and notes that her impression was hemorragic shock. No emesis was noted in any of the airways. Histopath was sent out and is pending. The DVM notes on discharge the temp was 101.7. Update 10.10.2011 Technical assessment: The complained batch was manufactured according to specifications. No deviations occurred. Update 17.10.2011: Post mortem radiographs of thorax and abdomen revealed air filled stomach. Owner declined necropsy. Doctors differential diagnosis is open: Anaphylactoid reaction, Cardiomyopathy related, vomit/aspiration or thrombosis. On 9/16/2011 owner allowed necropsy. The body was taken out of the freezer to thaw. On 9/18/2011 gross necropsy at the regular veterinary clinic: proximate cause of death appears to be acute pulmonary edema with subsequent body cavity effusion but cause of edema could not be conclusively determined: however significant numbers of eosinophils in alveolar fluid suggest an allergic/anaphylactic component. On 9/21/2011 histopathology report from an independent consultation service. Clinical history: Presented for straining to urinate: cystocentesis preformed, claws trimmed, dose of Advantage II applied: vomited during the ride home, following by severe respiratory distress, cyanosis and foaming at the mouth by the time it returned to hospital: arrested, CPR performed but rearrested and could not be revived: necropsy (body had been frozen and thawed) = good body condition, heart seemed small, bloody effusion in chest and abdomen, lungs appeared diffusely hemorrhagic, petechiae on omentum and bladder was full, mesenteric nodes slightly prominent. Diagnosis: A. Heart - Mild mutifocal acute or subacute myocardial necrosis B. Lung - Marked pulmonary congestion and edema with mild eosinophilic pneumonia, pulmonary artery smooth muscle hypertrophy. C. Kidney - Mild to moderate medullary fibrosis and tubular degeneration. Comments: This is a complex case. and the relative roles of the various lesions is difficult to determine. The proximate cause of death appears to be acute pulmonary edema and subsequent body cavity effusion. Significant numbers of eosinophils in the alveolar fluid suggest an allergic/anaphylactic component: however, typical lesions of underlying feline asthma were not appreciated. The etiology of feline pulmonary artery hypertrophy is still unclear: some but not all cases are attributed to previous parasite exposure or chronic hypertension. It is also unclear if this lesion is always associated with hemodynamic alterations that are of pathologic significance. The small heart size could be due to hypovolemia from the body cavity effusions: there is no obvious cardiomyopathy. Myocardial necrosis is very unusual finding in cats: it was not possible to determine if it was a result of tissue hypoxia due to pulmonary edema or primary cause of cardiac dysfunction leading to pulmonary edema. The latter seems less likely based on the small size and number of necrotic foci in the heart. No further information 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 inconsistent with pharmaco-toxicological product profile and experience. Post-mortem examination revealed myocardial necrosis and pulmonary edema but pathogenesis still unclear. The necropsy results indicate that other etiologies could be contributing facts in the clinical signs and death. based on available information a product relation was ruled out. No quality issues were noted upon product investigation.