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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0471

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0078493 (Report 464603)

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.

20-DEC-17

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

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. Unknown

Product Name: Advantage II (cat-unspecified)

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXIFEN
      • Guarantee/concentration .46 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Cat

  • 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 an unknown date in approximately Jul 2017, an 11 year old, 18 pound, neutered, male, Maine Coon Cat feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in approximately Sep2017 the cat was pruritic and had fleas. The owner applied 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically to the cat. On an unspecified date in approximately Oct 2017 the cat continued to have fleas and the pruritus increased. The owner applied 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically to the cat. On an unspecified date in Nov2017 the cat had 1 Seresto cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unspecified date in approximately Nov2017 the owner applied 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically to the cat.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Male

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

8.165

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea

12. How long did the symptoms last?

Persisted until death

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 late Nov2017 the cat exhibited vomiting and diarrhea. On an unspecified date in Dec2017 the pruritus worsened, fleas continued to be found and vomiting and diarrhea continued. On 19 Dec2017 the cat died. It was unknown if the cat was treated by a veterinarian for the signs. No necropsy was performed. No further information is expected. This case is closed. The intent of the call was to discuss product use in other pets and not to report the death of the cat.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Advantage II (cat-unspecified) N - Unlikely SLEE/fleas. Reported pruritus is not expected with appropriate topical product use. If any, skin reaction would be located at the application site. Skin disorder in this case rather associated with current flea infestation. However, presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Animal received regular treatments. However, a break in treatment probably induced the rebuilding of the flea population in the environment. The new treatment does not cover the flea cycle since the break. As existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, a re-infestation from the environment is likely. Therefore a lack of efficacy cannot be considered. Reported digestive disorders are unspecific and may have multiple other causes. Oral ingestion of product was not observed. Further, death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Other unrelated causes are more probable in this geriatric cat. Moreover, the intent of the call was to discuss product use in other pets and not to report the death of the cat. Finally, considering long time to onset and fatal outcome, a product involvement is unlikely. Seresto Cat N - Unlikely SLEE/fleas. Reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure reported. Reported pruritus is not expected with appropriate topical product use. If any, skin reaction would be located at the application site of the collar. Skin disorder in this case rather associated with current flea infestation. However, presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Unknown if re-infestation from infested environment (e.g. by means of other untreated animals, wildlife) occurred. Reported death is 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. Other unrelated causes are more probable in this geriatric cat. Moreover, the intent of the call was to discuss product use in other pets and not to report the death of the cat. Even though time to onset is unknown, considering products known safety profile and fatal outcome, a product involvement is unlikely.