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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3924

2. Registrant Information.

Registrant Reference Number: 2015TH264

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Blvd

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L9W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

26-JUL-13

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 - 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).

Owner applied collar July 26 2013

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

Cat / Chat

3. Breed

Domestic short hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

13.6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Abnormal behaviour
  • Gastrointestinal System
    • Symptom - Other
    • Specify - malocclusion

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?

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 26Jul2013, an approximately 5 year old, 13.6 pound, neutered, male, Domestic Shorthair, in fair condition, with a history of a severe flea infestation and severely decayed teeth, had one Seresto Cat Collar (Flumethrin-Imidacloprid) placed around his neck by the owner. Approximately one hour after the collar was placed, the cat started drooling and behaving uncharacteristically. Approximately two hours later, the owner removed the collar from the cat. On 29Jul2013, the cat was examined at the veterinary clinic and a malocclusion was diagnosed. The owner declined pre-anesthetic bloodwork. The cat was sedated with tiletamine/zolazepam and maintained on inhalant isoflurane gas. Two severely decayed teeth were extracted. The cat was then administered an injection of penicillin and an unspecified anti-inflammatory. The cat was then placed in a kennel to wake up from the procedure; recovery was uneventful. However, 1.5 hours later, the cat was found dead in the cage. On 30 Jul 2013, a necropsy was performed and the cause of death was perianesthetic death. No further information 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

N- Unlikely. Reported behavioural sign may be a reaction to uncomfortable feeling of collar, particularly in individuals not used to it. Drooling also not expected following correct product application, and as no oral product exposure was reported. Time to onset short and for behavioural disorder and drooling compatible with product application. However, reported musculoskeletal disorder and death not expected after use of the product as inconsistent with pharmaco- oxicological product profile. Cat has history of decayed teeth, which probably is cause of jaw disorder or vice versa, and may also be cause of drooling. Cat had anaesthesia and surgery prior to death, which are probable cause. Time to onset for latter signs also argues against product relation as collar had been already removed approx. 3 days before. Necropsy diagnosis of perianesthetic death may lead to the conclusion that the felines illnesses combined with anesthesia contributed to the feline's death. Overall, a product relation thus is deemed to be unlikely