Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0799

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0000433 (Report 541476)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

04-JAN-19

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

28-DEC-18

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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar Unknown

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

---

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 an unknown date in Mar 2018, a 5 year old, male, Retriever (Labrador, Black) canine, of unknown weight, reproductive status, and condition, with no known concomitant medical conditions, had one Seresto Dog (unspecified) (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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

>6 mos / > 6 mois

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• Renal System
  • Symptom - Renal failure

• General
  • Symptom - Death
  • Symptom - Parasitism
  • Specify - Other abnormal test result NOS: Lyme disease

12. How long did the symptoms last?

Persisted until death

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?

4

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 an unknown date in Nov-2018, after approximately 8 months of use, the collar was removed. On approximately 28-Dec-2018, the canine became anorexic. The canine was examined by a veterinarian and bloodwork was performed. The canine was diagnosed with acute kidney failure and Lyme disease. The canine was hospitalized on dialysis. On 29-Dec-2018, the canine was transferred to a university clinic, continued on dialysis, and had a blood transfusion. On 01-Jan-2019, the canine died and a necropsy was performed; the results were unknown. No further information is expected. Case is closed.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

N - Unlikely Acute renal failure is neither expected nor inline with products pharmaco-toxicological product profile. However sign may be consequence of diagnosed lyme disease. In this case, no ticks seen on the dog. In case of attachment, ticks will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. However, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases such as diagnosed lyme disease cannot be excluded while the collar is worn and simply reflects the labeled claim of efficacy that is not 100% against ticks especially when infestation pressure is high. Thus, infection with tick borne diseases despite wearing a collar can occur exceptionally and is consistent with the product's claimed efficacy. This issue is addressed in the product information. Reported anorexia is an unspecific sign and likely associated with earlier described signs. Death is 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. Product has wide margin of safety. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover all signs were reported after collar removal. Animal likely died due to acute renal failure. Time to onset is long. Considering all aspects, product relation is unlikely.