Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-3431

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2013- US0000640

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.

01-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

05-JAN-13

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. Unknown

Product Name: advantage II dog, unknown size

• 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.

Unknown

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 05-Jan-2013, an 11 month old Rottweiler canine, in goodcondition, that was bred during her first heat cycle and currentlypregnant and ready to begin welping, was administered 1 tube ofAdvantage II (dog unspecified) of an unknown size oncetopically route by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

rottweiler

4. Number of animals affected

11

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Respiratory System
  • Symptom - Difficulty Breathing

• General
  • Symptom - Vocalizing
  • Symptom - Hypothermia
  • Symptom - Dehydration
  • 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?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify mother of the pups was treated with advantage II

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

13 hours post application the bitch began welping at her expected delivery time. The first pup was stillborn (stillborn pup was sharing a sac with another pup) and she delivered 13 pups total within the next 5 hours. Approximately 19 hours post application, after the pups had attempted to nurse, the 12 pups began vocalizing and 6 passed away. The owner took the remaining 6 pups to the veterinarian. All of the pups had very low temperatures and were dehydrated. One of the pups presented gasping for air and was immediately given oxygen but passed away within 5 minutes. 1 of the pups was gasping and was euthanized before receiving any treatments. 1 of them received aubcutaneous fluids and oxygen but passed away approximately 5 minutes later. The other 3 pups were also administered subcutaneous fluids only as they were not having any breathing issues. The remaining 3 pups were sent home with the owner. Once home, 1 of the remaining 3 nursed on the mom and then, approximately 15 minutes later, passed away. The owner has continued to bottle feed the 2 remaining pups and both of the pups and the mom are asymptomatic. No more information is expected. This case is closed. Note: The veterinarian believed the cause of the events to be more likely associated with the bitch being bred at a young age

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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 Reported signs are not expected following appropriate product application as inconsistent with pharm.-tox. product profile. Topical administered product does not exert any influence on puppies in utero and new born. Oral ingestion of product by puppies not reported. Licking application site not expected due to rather young life age of puppies. Other causes more probable, e.g. too early breeding, intrauterine infection may have led to birth of weak puppies. DVM suspected different causes as well. No necropsy available. Though close time to onset, more likely coincidental occurrence. Considering all aspects, a product connection is deemed to be unlikely.