Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-7169

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0068610 (Report 611323)

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.

20-NOV-19

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

01-OCT-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. 11556-155

Product Name: Seresto Cat collar

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: COLLAR

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 01-Sep-2019, a 13 year old, 22 pound, neutered, male, American Shorthair cat, in unknown condition, that was administered an unknown dose of an unspecified thyroid medication since an unknown date in approximately 2017, with a concomitant medical condition of unspecified thyroid issues, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck 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

American Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

9.98

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hiding
  • Symptom - Abnormal behaviour
  • Specify - Behavioural disorder NOS

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Other
  • Specify - Circling - behavioural disorder (see also 'Neurological disorders')

• Gastrointestinal System
  • Symptom - Weight loss

• General
  • Symptom - Death

• Blood
  • Symptom - Anemia

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

• Skin
  • Symptom - Discolouration
  • Specify - Skin and hair discolouration

• General
  • Symptom - Parasitism

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?

1

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 01-Oct-2019, the cat exhibited a behavior change, hiding, localized pruritus at the tail base, skin discoloration, hair discoloration, and circling while scratching. Fleas were visualized on the cat. The cat was evaluated by a veterinarian. Upon exam the cat had lost weight to approximately 13 pounds. Unspecified blood work was performed and exhibited unspecified anemia and a renal disorder nos. The cat was administered an unspecified injection by the veterinarian and hospitalized. On approximately 02-Oct-2019, the cat died. No autopsy was performed. Follow-Up received on 2nd Dec 2019: No more information is expected.

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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

SLEE/fleas. Reported behaviour signs are unspecific and may have numerous other causes. Signs are not expected to appear after long time and may be associated with reported skin disorders and flea infestation. Pruritus is not typically seen with appropriate topical product use. Pruritus in this case rather associated with current flea infestation. However, presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Unknown if re-infestation from infested environment (e.g. by means of other untreated animals, wildlife) occurred. In this case product was applied previously; however, exact duration and dates of treatment are unknown. Additionally reported skin discoloration and hair discoloration are not expected with topical product administration. Other causes must be considered. Further reported weight loss is not expected after topical product application and may be associated with concomitant thyroid issue. Diagnosed anaemia and renal disorder which was followed by death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Death was likely associated with diagnosed anaemia and renal disorder. Other causes are more probable in this geriatric animal. Also some information missing regarding animal health status and necropsy report. Considering all aspects, a product involvement is unassessable.