Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1231

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0003827 (Report 469696)

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

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

06-FEB-18

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

03-JAN-18

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)

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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 %

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7. b) Type of formulation.

Other (specify)

Spot-on

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).

On 03-Jan-2018, a 10 year old, 10 pound, neutered, female, Domestic Longhair feline, in unknown condition, with concomitant medical conditions of anxiety, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. This product was identified as suspect counterfeit by Amazon.

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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

4.536

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Bradycardia

• General
  • Symptom - Hypothermia

• Respiratory System
  • Symptom - Other
  • Specify - Shallow breathing

• Renal System
  • Symptom - Urine discoloration

• Gastrointestinal System
  • Symptom - Anorexia

• Respiratory System
  • Symptom - Difficulty Breathing

12. How long did the symptoms last?

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

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?

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

Approximately 6 hours post application, the cat exhibited bradycardia, hypothermia, shallow breathing, dark urine, anorexia and agonal breathing. The cat was not examined by a veterinarian and the clinical signs continued. On 06 Jan 2018, the cat died at home. No necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

O-Unassessable: On 03 JAN 2018, a 10 year old feline, in unknown condition, was administered one tube of Advantage II Large Cat topically by the owner. Approximately six hours post application the cat exhibited bradycardia, hypothermia, shallow breathing, dark urine, anorexia and was agonal. On 06 JAN 2018, the cat died at home. No veterinary attention was sought and no necropsy was initiated or carried out. Reported clinical signs, particularly death, are not expected with appropriate topical product use as inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage was tolerated by cats without showing any side effect. Product was suspected to be a counterfeit. The time to onset is compatible. Overall, product involvement is rather unlikely but state of knowledge is not sufficient for exclusion with the necessary certainty the more so as unknown if original product was used.