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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-2741

2. Registrant Information.

Registrant Reference Number: 2016KP059

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-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-DEC-15

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
    • 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 approximately 15-Sep-2015, a 15 month old, 23 pound,neutered, male, Pug canine, in good condition, with no known concomitant medical conditions, had 1 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

Other

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 )

1.3

7. Weight (provide a range if necessary )

23

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 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Convulsions
    • Symptom - Seizure
  • Blood
    • Symptom - Leukocytosis
    • Symptom - Leukocytosis
    • Specify - Neutrophilia
    • Symptom - Other
    • Specify - Hypophosphataemia

12. How long did the symptoms last?

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

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?

1

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 15Dec2015, the dog exhibited lethargy. The dog was examined by a veterinarian, tested positive for lyme disease, was given a lyme vaccine and started on minocycline. The dog returned to the clinic approximately 2 hours later, foaming at the mouth and shaking, and was treated with dexamethasone and diphenhydramine injections. On 16Dec2015, the dog returned to the clinic seizuring, foaming mouth, and convulsing. The dog had additional bloodwork performed the results were unknown. The dog was started on zonisamide. On 17Dec2015 the dog died at home. No necropsy was performed. No further information is expected; this case is closed. Follow up received on 14 Jan 2016: On 15-Sep-2015, a 15 month old, 23 pound, neutered, male, Pug canine, in good condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 15 Dec 2015, the dog exhibited lethargy. The dog was examined by a veterinarian, tested positive for Lyme disease, was given a Lyme vaccine and started on minocycline. Approximately 1 hour later, the dog had an episode of foaming at the mouth and shaking. He was returned to the clinic, where he was examined and found to be normal. He was treated with dexamethasone and diphenhydramine injections. On 16 Dec 2015, the dog had another similar episode during the day. That evening, the dog had a third episode. He was returned to the hospital. While at the hospital, the dog had a fourth episode where the dog initially was shaking, then had facial twitching, foaming at the mouth, and a seizure. Blood work was performed and the only abnormalities were decreased phosphorus, slight leukocytosis, neutrophilia and monocytosis. Toxic exposure to something in the household could not be ruled out. The dog was started on zonisamide. On 17 Dec 2015 the dog died at home. No necropsy was performed. No further 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

Lethargy is an unspecific sign and may have multiple possible causes in an animal. Lyme disease is a tick borne bacterial disease. In this case, no ticks seen on dog. Even as per the labelled claim of efficacy of the product, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn, especially when infestation pressure is high. Foaming at the mouth and shaking are not anticipated with appropriate topical product administration. Multiple episodes of these signs along with facial twitching were likely introducing the subsequent seizure. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration. Even with oral product exposure, which was anyway not reported in this case, only transient gastrointestinal signs would be expected. The abnormal blood parameters are unexpected may be associated with other reported signs. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. In this case, Lyme disease, other medications administered (including a vaccine) and the suspected toxic exposure are more likely to have contributed to the signs. Finally time to onset was exceptionally long (3 months). Considering all these aspects, although no necropsy was performed, product relation was deemed to be unlikely.