Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0704

2. Registrant Information.

Registrant Reference Number: 2017KP006

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.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

05-JUL-14

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. 11556-125

Product Name: advantage II medium dog

• 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.

1

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 04Jul2014, a 10 year old, 14 pound, intact, female, Pinscher (Miniature) canine, in critical condition, with mammary gland tumors, asthma and difficulty breathing treated with unspecified medications and herbal medications,,was administered 1 tube of Advantage II Medium Dog(Imidacloprid-Pyriproxyfen) topically 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Pinscher

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

14

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Neoplasia

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 05Jul2014, the dog developed generalized pruritus. As of 01Aug2014 the pruritus continued and the owner applied another dose of Advantage II Medium. Follow up received on 19th Oct 2016: On 01Aug2014, the pruritus continued and the product was re-applied. On an unknown date, in 2016, the dog was diagnosed with cancer and died. No known necropsy was performed. The communication was not to report this event, but to discuss a different dog in the household. 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

Generalized pruritus is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Neoplasia and subsequent death are not expected as inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety and no carcinogenic potential. The oral LD50 in rat is 642 mg/kg BW. A 20-fold over dosage is tolerated by dogs without showing any side effect. Animal was of an advanced age and in a critical condition with several concomitant conditions, particularly mammary gland tumour, which may have contributed to the signs. Moreover, the intent of initial communication was not to report this event, but to discuss a different dog in the household. Even though time to onset was short for initial pruritus; it was long for other serious signs. Considering all aspects, although no known necropsy was performed, product relation was deemed unlikely.