Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4938

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0042234

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.

11-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

30-JUN-17

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 Collar Cat

• Active Ingredient(s)
  • FLUMETHRIN
  • 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).

An 11 year old, 15 pound, neutered, female, Domestic Shorthair feline, in unknown condition, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the 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

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

6.8

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• Liver
  • Symptom - Other
  • Specify - Unknown hepatic disorder

• Skin
  • Symptom - Other
  • Specify - Unknown Skin disorder

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

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia

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

• Skin
  • Symptom - Dry skin
  • Specify - Dry lips

• General
  • Symptom - Dehydration

• Renal System
  • Symptom - Urinary incontinence

• General
  • Symptom - Lethargy

• Blood
  • Symptom - Anemia

• General
  • Symptom - Death

12. How long did the symptoms last?

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

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

On 24-Jun-2017, an 11 year old, 15 pound, neutered, female, Domestic Shorthair feline, in unknown condition, with concomitant medical conditions of anemia, weight gain, fleas, and skin irritation around chin and ears, being administered an unknown fish oil spray topically daily as needed since approximately May2017, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 30-Jun-2017, the feline exhibited anorexia, adipsia, clear nasal discharge, dry lips, dehydration, urinary incontinence, and lethargy. On 03-Jul-2017, the collar was removed and the feline was examined by a veterinarian. Unspecified bloodwork was performed and revealed worsened anemia and other unspecified abnormalities. The cat was diagnosed with an unknown renal disorder, an unknown hepatic disorder and an unspecified skin and tissue infection.. The feline was administered an unknown volume of fluids (route unknown) and an unknown dose of a an unknown antibiotic by mouth daily. On 09-Jul-2017, the feline died. 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

N - Unlikely Initially reported systemic signs are unspecific and may have numerous other causes. Even though systemic signs like anorexia, adipsia, lethargy may occur initially after collar administration, dehydration would not be expected. The other signs reported along side such as nasal discharge, dry lips and urinary incontinence too are unexpected with product use. Most likely reported signs were consequences of the later diagnosed renal and hepatic disorder which ultimately culminated in death. The worsened anemia and other abnormalities, though unspecified, were most likely associated with altered renal and hepatic function. Skin infection may have been a consequence of pre-existing irritation, aggravated by the critical condition of the animal. Overall, serious signs involving vital organ systems as well as a fatal outcome are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such 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. Further, pre-existing concomitant medical condition of anaemia and weight gain indicate that the later diagnosed conditions may have been pre-existing and were co-incidentally diagnosed after collar application. Moreover, animal was of advanced age and thus pre-disposed to reported medical issues. Even though time to onset is short for the initial reported systemic signs, it is inconsistent for the other reported signs, particularly the serious signs. Considering all the above aspects, product relation is deemed to be unlikely.