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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4160

2. Registrant Information.

Registrant Reference Number: UUSA-BAYERBAH-2017-US0035175

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.

11-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

17-JUN-17

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 Large Dog

  • 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).

An 8 year old, 22.8 pound, neutered, male, Terrier (Rat) canine, in unknown condition, with no known concomitant medical conditions, 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

Terrier (Rat)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

10.34

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Fasciculations
  • General
    • Symptom - Abnormal behaviour
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Vomiting
  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Clingy
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Proprioception deficit
  • General
    • Symptom - Other
    • Specify - Hyperaemic mucous membrane
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Trembling
  • General
    • Symptom - Hypothermia
  • Renal System
    • Symptom - Renal failure
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
    • Specify - dragging of hind paws

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?

Unknown

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 16-Jun-2017, an 8 year old, 22.8 pound, neutered, male, Terrier (Rat) canine, in unknown condition, with no known concomitant medical conditions, who was administered 250 mg methocarbamol every 12 hours since approximately 2015, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The version date on the tin packaging of V 01/2016 is not consistent with distributed product and the tin was also a different color white on the outside than tins at the veterinary clinic (possible counterfeit). On 17-Jun-2017, the canine vomited a large amount after getting into the cat's food. On 18-Jun-2017, the canine exhibited generalized pruritus and clingy behavior. On 19-Jun-2017, the canine vomited clear fluid once and resolved and exhibited dragging of hind paws(proprioceptive deficits), anorexia, hyperemic oral mucosa, and lethargy. The collar was removed and the canine was bathed in an liquid dish soap. Immediately post bathing the canine began to tremble and his temperature was 97 degrees Fahrenheit. One hour post onset the trembling resolved. The canine was evaluated by a veterinarian. No known temperature was taken. The canine was administered injections of diphenhydramine and maropitant citrate and was started on an oral dog toothpaste. Approximately 4 hours post the initial bath, the canine was bathed again in a human baby shampoo on the recommendations of the veterinarian. On 20-Jun-2017, the canine exhibited skin fasciculation when touched and growled twice at the owner. The canine was examined by a veterinarian. Blood work was performed; the results were unknown. The canine was hospitalized and started on a constant rate of unspecified fluids intravenously. The canine had a seizure and was administered an unspecified dose of valium via an unknown route. The canine died approximately 10 minutes after the onset of the seizure. It was unknown if a necropsy examination was performed. Follow-Up Received on 23rd Jun 2017: No necropsy was performed. On 22Jun2017, the bloodwork returned and the veterinarian diagnosed the dog with acute kidney failure.


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 sign such as vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal signs may occur shortly after product application, vomiting in this case rather related to ingestion of cat food. Pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) have to be considered as well. Initial pruritus may represent a reaction to the collar in a sensitive animal. Reported behavioural sign such as being clingy may occur initially after collar administration. Time to onset short for the signs. Reported hyperemic oral mucosa is unspecific, unusual and are not expected based on the pharmacological product profile. Reported dragging of hind paws is not typically seen with appropriate topical product administration. No oral product exposure reported. Considering short time to onset, these signs may reflect a mere behavioural reaction to the collar than a true systemic condition. The collar was removed and bathed. Subsequent trembling and hypothermia were likely related to the bathing. Skin fasciculation was observed after collar removal and bathing and thus is not considered product related. The same applies for growling. Dog received treatments and developed seizures after that. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures/convulsions were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. In this case, use of another drug e.g. methacarbamol role of which causing seizure can not be ruled out completely. Death and later diagnosed acute renal failure are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Fasciculation, seizure, death and diagnosed acute renal failure occurred after collar removal and thus were not product related. Animal involved in this case likely died due to diagnosed acute renal failure. Although first signs started shortly after product application, a relation with seizure, renal disorder and death can be ruled out. In the end, the case was considered unassessable.