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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1289

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0007273 (Report 623215)

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.

04-MAR-20

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

Unknown

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 Large Dog

  • 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 03-Mar-2020, a 3 year old, 24 pound, neutered, male, overweight Pug canine, with the concomitant medical condition of being overweight, 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

Pug

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

10.86

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Blood
    • Symptom - Other
    • Specify - Swollen lymph node
  • Skin
    • Symptom - Bruises
  • General
    • Symptom - Hypothermia
  • Cardiovascular System
    • Symptom - Hypotension
  • Respiratory System
    • Symptom - Dyspnea
  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Cyanosis
  • General
    • Symptom - Lethargy
    • Symptom - Edema

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

Approximately 1 hour post administration, the canine exhibited swelling of the left mandibular lymph node and the collar was removed by the pet owner. On 04-Mar-2020, the canine exhibited a swelling and edema on the right mandibular lymph node and both axillary lymph nodes, then presented to a veterinarian. Upon examination the canine exhibited bruising on the abdomen, body temperature dropped from 97.9 to 96.9 degrees Fahrenheit, hypotension and dyspnea. The canine was also depressed. The canine was administered 1.4 cc of dexamethasone 4 mg/ml and 0.5 cc of dpehenhydramine 50 mg/ml. The owner administered albuterol to the canine on the recommendations of the veterinarian. The signs improved, but continued. The canine was examined by another veterinarian and was cyanotic. The canine was intubated with a 5.0 endotracheal tube with difficult placement and placed on oxygen. An intravenous catheter was placed in the hind right leg and 3 ml of atropine were administered intravenously. Chest compressions were performed for 5 minutes and cardiopulmonary resuscitation was discontinued at the owner's request. The canine died. No known necropsy was performed and the canine was cremated. No new medical information is expected. This 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

O - Unclassifiable/unassessable Reported signs including fatal outcome 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. Reported cyanosis in this case may be associated with dyspnea. Depression is unspecific and likely associated with other reported signs. Skin disorder like bruising on abdomen is not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorders are not expected. Most of the signs occurred after collar removal. Nonetheless, in the absence of necropsy results, a confirmative cause cannot be ascertained. Considering limited information, a product relation for the case was unassessable.