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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4032

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0012433

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.

30-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

31-MAR-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. Unknown

Product Name: Seresto Collar unknown

  • 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.

Unknown

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).

Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck of the animal 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

8.528

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Respiratory System
    • Symptom - Dyspnea
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Constipation
    • Specify - Not defecating
  • Nervous and Muscular Systems
    • Symptom - Collapse

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.

No

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 an unspecified date in 2017, a 10 year old, 18.8 pound, neutered, female, Shih Tzu canine, in unknown condition, with concomitant medical conditions of elevated liver enzymes, and dermal mass on right flank, with history of mast cell sarcoma, had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 27-Mar-2017, the dog was examined by a veterinarian. The dog was vaccinated with unspecified vaccines and unknown bloodwork was performed. The dog continued to have elevated liver enzymes. On 31-Mar-2017, the dog exhibited dyspnea. The owner bathed the dog with an unspecified shampoo and the collar was removed. On 01-Apr-2017, the dog exhibited anorexia, adipsia, not defecating, and ataxia. No medical intervention was sought . On 02-Apr-2017, the dog died and no necropsy was performed. No more information is expected. Case is closed. Follow up received on 5th Apr 2017: On 27-Mar-2017, a 10 year old, 18.8 pound, neutered, female, Shih Tzu canine, in unknown condition, with concomitant medical conditions of elevated liver enzymes, and dermal mass on right flank, with history of mast cell sarcoma, had a routine examination by the veterinarian, vaccinated with unspecified vaccines and unknown bloodwork was performed;the concomitant elevated liver enzymes continued. On 28Mar2017, the dog had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 31-Mar-2017, the dog exhibited dyspnea. The owner bathed the dog with an unspecified shampoo and the collar was removed. On 01-Apr-2017, the dog exhibited anorexia, adipsia, not defecating, ataxia and collapsed after a walk. No medical intervention was sought. On 02-Apr-2017, the dog died and no necropsy was performed. No more information is expected. 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 dyspnoea, anorexia and adipsia are unspecific signs and may have various other causes. Not defecating is not expected after product application, in this case it may be associated with anorexia. Ataxia and collapse are not anticipated with appropriate topical product administration. No oral product exposure reported. Death is not expected following appropriate topical product application as inconsistent with products 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Animal involved in this case was geriatric and had concomitant condition of elevated liver enzymes, dermal mass on right flank, with history of mast cell sarcoma which likely have contributed to reported signs and outcome. Even though time to onset is consistent, most of the signs were observed after collar removal. Although a relation to the product is deemed unlikely taking the animal's underlying medical problems and the product's safety profile into account, considering that the final cause for death remains unknown, the case is considered as unassessable.