Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-4454

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0040124 (Report 582419)

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.

16-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

29-JUN-19

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 approximately 28-Jun-2019, a 10 year old, approximately 9 pound, intact, male, Domestic Shorthair cat, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner.

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

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

4.08

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Respiratory System
  • Symptom - Runny nose
  • Specify - Nasal discharge

• Skin
  • Symptom - Other
  • Specify - Malodour

• Gastrointestinal System
  • Symptom - Weight loss

• Renal System
  • Symptom - Other
  • Specify - Urinary bladder disorder NOS

• General
  • Symptom - Polydipsia
  • Symptom - Death

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?

3

Day(s) / Jour(s)

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

On approximately 29-Jun-2019, the cat developed excessive thirst. On approximately 05-Jul-2019, the cat developed weight loss. On 11-Jul-2019, the cat developed an abnormal body odor and nasal discharge. On 12-Jul-2019, the cat was evaluated by a veterinarian weighed 7 pounds. Unspecified blood work was performed and the cat was diagnosed with decreased kidney function and a bladder infection. Intravenous fluids and unspecified antibiotics were administered and continued to be administered to the cat. The cat continued to be hospitalized and the clinical signs continued unchanged. Follow up received on 2 Aug 2019: The cat continued to be hospitalized and the clinical signs continued unchanged. On an unknown date in Jul 2019, the cat was re-evaluated by a veterinarian and hospitalized and released after 3 days. The clinical signs continued. On 28 Jul 2019, the cat was re-evaluated by a veterinarian and administered an unspecified amount of injectable fluids. On 29 Jul 2019, the cat was re-evaluated by a veterinarian; the owner elected to humanely euthanize the cat. No known necropsy was performed. No more information is expected. This case is closed.

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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 - Unclassifiable/unassessable Excessive thirst is unspecific sign and may have other numerous causes. Malodor after topical product administration is not anticipated. Apart from that, the bad smell on administration of product is subjective to the individual concerned. Malodor may have multiple other causes (e.g. diet, humidity, fur condition) and is rather connected with the animal than the product. Reported weight loss, nasal discharged, diagnosed decreased kidney function, bladder infection and need for death by euthanasia are not expected with use of product as inconsistent with the pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Other unrelated causes must be considered in this geriatric animal. Time to onset is short for initial reported systemic sign but long for later reported signs. Overall, a relation to this case is considered as unassessable.