Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1882

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0009485 (Report 551919)

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.

26-MAR-19

5. Location of incident.

Country: UNITED STATES

Prov / State: MONTANA

6. Date incident was first observed.

20-MAR-19

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 Large Dog

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

On 17-Mar-2019, a 9 year old, 75 pound, neutered, male, Collie canine, in unknown condition, with no known concomitant medical conditions, administered meloxicam by the owner since approximately 2017, had 1 Seresto Large Dog (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

Dog / Chien

3. Breed

Collie canine

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

34.02

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavioural disorder NOS ( staring behavior)

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Blood
  • Symptom - Other
  • Specify - Increased red blood cell count

• General
  • Symptom - Other
  • Specify - Other abnormal test result NOS
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Other
  • Specify - Gastric ulcer

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Difficulty walking
  • Symptom - Trembling

• Blood
  • Symptom - Other
  • Specify - Elevated blood urea nitrogen (BUN)

• Renal System
  • Symptom - Creatinine increased
  • Specify - Elevated creatinine

• Blood
  • Symptom - Hyperphosphatemia
  • Specify - Hyperphosphataemia

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?

8

Hour(s) / Heure(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 17-Mar-2019, a 9 year old, 75 pound, neutered, male, Collie canine, in unknown condition, with no known concomitant medical conditions, administered an unspecified dose of meloxicam by the owner since approximately 2019, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 20-Mar-2019, the dog vomited once. On 21-Mar-2019, the dog exhibited a staring behavior, ataxia and vomited once. The vomiting resolved in approximately 5 minutes. The dog was not examined by a veterinarian and the clinical signs continued. Follow up received on 26th Mar 2019: On 17-Mar-2019, a 9 year old, 75 pound, neutered, male, Collie canine, in unknown condition, with no known concomitant medical conditions, administered meloxicam by the owner since approximately 2017, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 20-Mar-2019, the dog vomited once and exhibited lethargy. On 21-Mar-2019, the dog exhibited a staring behavior, ataxia and vomited once. The dog was examined by a veterinarian and diagnosed with a gastric ulcer. The meloxicam was discontinued and the dog was started on maropitant citrate. On 22Mar2019, the dog was re-evaluated by the veterinarian and exhibited increased lethargy, inability to walk, and tremors; the other signs continued. Blood work was performed and showed increased blood urea nitrogen (45 mg/dl), increased creatinine (1.8 mg/dl), increased phosphorus (6.8 mg/dl) and elevated red blood cell count and hemoglobin (other abnormal test result NOS). The dog was hospitalized, started on intravenous fluids, and administered unspecified doses of aluminum hydroxide, enalapril and injectable ampicillin. Approximately 8 hours post hospital admittance, the dog died. No necropsy examination was performed. Follow up received on 4th Apr 2019: No further information is expected. This case is closed. Note: No quality issues were noted upon product investigation.

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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

O - Unclassifiable/unassessable Reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility and gastric ulcers). Though mild gastrointestinal signs may occur shortly after product application, other more severe gastrointestinal signs (like gastric ulcers in this case) is not typically seen with product use. No oral product exposure reported. Other causes are more likely, other product applied in parallel. Staring behaviour and lethargy are unspecific and may have numerous other causes. Moreover in this case, lethargy may be associated with vomiting. Neurological signs are not typically seen with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. The neurological signs may be associated with the later revealed increased phosphorus level in blood. Later finding abnormal blood values and reported death are 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. 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Time to onset is long. Animal's state of health is also unknown. Considering all aspects, a product involvement for the case is unassessable.