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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7946

2. Registrant Information.

Registrant Reference Number: 2016KP227

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

29-JUN-16

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

  • Active Ingredient(s)
    • FLUMETHRIN
    • 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 29Jun2016, a 7 year old, 21 pound, female, Pug canine,of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, had 1 SerestoSmall Dog (Flumethrin-Imidacloprid) collar placed around her 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Pug

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

21

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Eye
    • Symptom - Other
    • Specify - Periorbital oedema
  • Respiratory System
    • Symptom - Tachypnea
  • Gastrointestinal System
    • Symptom - Vomiting
  • Eye
    • Symptom - Red eye
  • Respiratory System
    • Symptom - Dyspnea
  • Gastrointestinal System
    • Symptom - Weight loss
  • Eye
    • Symptom - Discharge eye
    • Symptom - Other
    • Specify - Corneal oedema
    • Symptom - Conjunctivitis

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?

2

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

Approximately 3 hours post product application, the canine became lethargic. On 30Jun2016, the canine developed periorbital edema, tachypnea and exhibited vomiting approximately 2 times that resolved within approximately 15 minutes. On 03Jul2016, the collar was removed. On 07Jul2016, the clinical signs continued and the canine was examined by veterinarian at an emergency clinic. The canine exhibited eye redness and was administered oxygen therapy. Follow up received on 15th July 2016: 09Jul2016, the dog was released from the hospital. 10Jul2016, the dog passed away. No necropsy was performed. Follow up received on 27th July 2016: On 22Jun2016, a 7 year old, 21 pound, female, Pug canine, of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around her neck by the owner. Approximately 3 hours post product application, the canine became lethargic. 25Jun2016, the collar was removed. On 30Jun2016, the canine developed periorbital edema, tachypnea and exhibited vomiting approximately 2 times that resolved within approximately 15 minutes. On 07Jul2016, the clinical signs continued and the canine was examined by veterinarian at an emergency clinic. The canine exhibited eye redness and was administered oxygen therapy. Radiographs were performed and results are unknown. The canine was hospitalized and treatments are unknown. 09Jul2016, the dog was released from the hospital. 10Jul2016, the dog died. No necropsy was performed. No more information is expected. The case is closed. Follow-up received on 3rd Aug, 2016: On 29 Jun2016, a 7 year old, 21 pound, female, Pug canine, of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around her neck by the owner. Approximately 3 hours post product application, the canine became lethargic and vomited once. On 30Jun2016, the canine developed periorbital edema, tachypnea, and vomited approximately 2 times. The vomiting resolved within approximately 15 minutes. On 03 July 2016, the signs continued and the collar was removed by the owner. The lethargy improved. On 07Jul2016, the clinical signs continued and the eyes were red and had discharge. The canine was examined by veterinarian at an emergency clinic. On exam, the left eye was cloudy and had conjunctivitis. The dog was tachypneic and short of breath. The dog experienced weight loss and was 17.6 pounds. Radiographs were performed and results are unknown. The patient was hospitalized and placed in an oxygen cage and administered 0.7 ml ceftiofur sodium intramuscularly, 1.0 ml of an unknown medication subcutaneously, 0.5 ml of dexamethasone by injection, 0.34 ml diphenhydramine by injection, an unknown amount of carprofen subcutaneously, and an unknown eye ointment placed oticly. On 08 Jul 2016, the signs continued and the canine remained in an oxygen cage. The canine was administered 0.7 ml ceftiofur sodium intramuscularly, 1 mL penicillin subcutaneously, and an unknown eye ointment placed oticly. On 09 Jul 2016, the signs continued and the canine remained in an oxygen cage. It was administered 0.7 ml ceftiofur sodium intramuscularly, 1 ml penicillin subcutaneously, and an unknown medication by an unknown route. The canine was discharged from the hospital and started on a regimen of prednisone 5 mg twice daily orally, Baytril (enrofloxacin) 68 mg 1 tab orally daily, and tramadol 50 mg on half tab twice orally daily by the owner. Bayer became aware of the involvement of Baytril on the last follow-up on 03 Aug 2016. On 10Jul2016, the dog died. No necropsy was performed. No more information is expected. The 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

Off-label use (dose too low). Lethargy is unspecific and may have numerous other causes, however may appear shortly after product application. The collar was removed after 3 days of wearing. After collar removal, dog showed eye disorders, respiratory disorders, weight loss, and vomiting. All these signs are not expected with appropriate topical product administration and as they appeared after collar removal, other unrelated causes are more likely. Signs went on and the dog was hospitalized but released from hospital approx. 2 weeks after collar removal. The dog died one day after release from hospital. Time between collar removal and death was 2 weeks which is a too long timeframe and thus product relation can be excluded. Death is not expected with product use and of course not after 2 weeks of collar removal. Oral exposure to the collar is not expected to cause serious sign 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. Even though some information is not available (health status, necropsy report), considering serious chronology and early removal of the collar, a product relation is considered as unlikely.