Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6621

2. Registrant Information.

Registrant Reference Number: 2016KP167

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

29-MAR-16

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.

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).

On approximately 15 Nov2015, a 16 year old, approximately10 pound, neutered, female, Domestic Shorthair feline, in fair condition, with concomitant flea allergy dermatitis and fleas,had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) 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 )

16

7. Weight (provide a range if necessary )

10

lbs

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

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Pruritus
  • Symptom - Rash

12. How long did the symptoms last?

Unknown / Inconnu

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

On approximately 29Mar2016, the cat developed generalized pruritus and rash on abdomen. On 12Apr2016 the collar was removed. The cat was not seen by a veterinarian and the clinical signs continued. Follow up received (29th Aug 2016): On an unknown date post collar application, in approximately May-2016, the cat had 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date in 2016 the owner used an unknown carpet spray flea treatment. Approximately 3 months post Advantage II Large Cat, in Aug-2016, the cat died. The cat was not examined by a veterinarian and it was unknown if a necropsy had been preformed. No further information expected. This case is closed. Note: Previous exposure was well tolerated by the animal.

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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

Generalized pruritus and rash on abdomen are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Moreover, in this case, these signs are not related with the product as they occurred before product application. Death is not expected either as it is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Animal involved in this case was geriatric with a fair health condition. Also, previous exposure was well tolerated by the animal. Time to onset of 3 month is too long. Overall, even though no necropsy was performed, considering the known safety profile of the product, a product relation is unlikely.