Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6459

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0061768 (Report 604621)

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.

14-OCT-19

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

05-OCT-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 Small 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 03-Oct-2019, an 8 year old, 14.7 pound, female, Terrier (Jack Russell) canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small 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

Jack Russell Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

6.668

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

• Eye
  • Symptom - Itchy eye

• Gastrointestinal System
  • Symptom - Vomiting

• Eye
  • Symptom - Watery eye

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Diarrhea

• Respiratory System
  • Symptom - Pneumonia

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Other
  • Specify - Undigested food
  • Symptom - Other
  • Specify - Megaoesophagus

• Eye
  • Symptom - Corneal abrasion

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

• General
  • Symptom - Other
  • Specify - consolidation of right lung

• Skin
  • Symptom - Pruritus

• Cardiovascular System
  • Symptom - Heart murmur

• General
  • Symptom - Other
  • Specify - Hyperaemia

• Blood
  • Symptom - Leukopenia
  • Specify - Lymphopaenia

• Gastrointestinal System
  • Symptom - Abdominal distension

• Cardiovascular System
  • Symptom - Heart murmur

• Eye
  • Symptom - Discharge eye

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?

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 05 Oct 2019, the dog exhibited vomiting and itchy and watery eyes. On 07 Oct 2019, the dog exhibited multiple episodes of vomiting and diarrhea. On 09 Oct 2019, the owner removed the collar. On 10 Oct 2019, the dog was examined by a veterinarian and a blood chemistry, electrolytes and blood count performed revealed an elevated red blood cell count of 9.16%, hemoglobin count of 21.g/dl, decreased lymphocytes 0.87 K/uL, and mild increased glucose at 153 mg/dl. A flourscein stain eye test was performed and the dog was diagnosed with bilateral corneal ulcers. The dog was administered 0.7 ml of cefovecin sodium subcutaneously, unspecified dose of oral nitenpyram and 150 ml of subcutaneous fluids. The clinical signs continued. On 13 Oct 2019, the dog was bathed with dish soap. On 14 Oct 2019, the dog exhibited lethargy. The dog was re-evaluated by the veterinarian, radiographs performed revealed continued undigested food and gas in the colon and small intestine. The dog was diagnosed with aspiration pneumonia, megaesophagus, bilateral corneal ulcers and was administered an injection of 0.7 ml cefovecin sodium and 160 ml of subcutaneous fluids. The dog was placed on tobramycin ophthalmic drops 1 drop in each eye every 12 hours. The clinical signs continued. On 16 Oct 2019, the dog was re-evaluated by the veterinarian, exhibited pruritus, radiographs of the abdomen and chest were performed and revealed an enlarged stomach, an interstitial pattern in the right caudal lung field. The dog was started on 25 mg oral marbofloxacin once a day, 500 mg of oral sucralfate twice a day and 5 mg of famotidine twice daily. The clinical signs continued. Owner administered unknown dosage of diphenhydramine orally. On 18 Oct 2019, the dog was evaluated by a new veterinarian and diagnosed with a grade 3/6 left systolic heart murmur, bilateral ocular discharge and moderate hyperemia. Radiographs performed and reveled a consolidation of the right lung, gas in the esophagus and stomach. The dog was administered an unspecified amount of subcutaneous fluids and placed on oral chewable amoxicillin/trihydrate/clavulanic acid. On approximately 21 Oct 2019, the dog had 2 seizures and died at home. No necropsy was performed.

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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 eye disorders of itchy, watery eyes, later reported corneal ulcers and ocular discharge are not expected after topical product application. No eye exposure of product reported. Time to onset for eye disorders is short, though. Reported digestive signs of vomiting and diarrhoea are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal signs may occur shortly after product application, they are not expected to appear with long time to onset. Pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) are more probable although not described. Diagnosed abnormal blood parameters and further reported such as gastric distension, pneumonia, megaesophagus, hyperemia, abnormal radiograph findings, heart murmur, seizure and death are not expected after topical product application, as these are inconsistent with the pharmaco-toxicological product profile. Moreover, these signs occurred long time after removal of collar, hence not related to the product. The collar was worn only for some days, however majority of signs, in particular severe signs and death, occurred long time after collar removal. The product has no systemic efficacy and thus other causes are more likely. Though a product relation is considered rather unlikely, due to limited information a relation for the case is considered unassessable.