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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4182

2. Registrant Information.

Registrant Reference Number: 2016KP086

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.

18-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

11-SEP-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. 11556-152

Product Name: advantage II large cat

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

Units: mL

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 01May2015, a 14 year old, 23 pound,neutered, male, Domestic Shorthair feline, in fair condition,with concomitant fleas, was administered 1 tube of AdvantageII Large Cat (Imidacloprid-Pyriproxyfen) topically 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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

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
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
  • Gastrointestinal System
    • Symptom - Diarrhea
  • Eye
    • Symptom - Pupil dilation
    • Specify - Mydriasis
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Tooth Disorder
  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Seizure
    • Symptom - Ataxia
  • Respiratory System
    • Symptom - Tachypnea
  • Gastrointestinal System
    • Symptom - Bloody vomit
  • Respiratory System
    • Symptom - Panting

12. How long did the symptoms last?

Unknown / Inconnu

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 approximately 11Sep2015, the feline developed generalized pruritus, a scab and multiple erythemic skin sore on his caudal back. He was not examined by a veterinarian and the clinical signs continued. Follow up received on 8th Apr 2016: On approximately 01May2015, a 14 year old, 23 pound, neutered, male, Domestic Shorthair feline, in unknown condition with concomitant fleas, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On approximately 03Mar2015 the cat developed twitching leg, diarrhea, mydriasis, and clenching teeth. On 18Mar2016 the cat developed seizure, ataxia, panting, vomiting blood, and died. No further information is expected. This case is closed. Follow up received on 15th Apr 2016: No necropsy was performed. Follow up received on 15th Apr 2016: On 08-Oct-2015, a 14 year old, 23 pound, neutered, male, Domestic Shorthair feline, in unknown condition with concomitant fleas, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On approximately 10Oct2015 the cat developed twitching leg, diarrhea, mydriasis, and clenching teeth (tooth disorder). On 18Oct2015 the cat developed seizure, ataxia, panting, vomiting blood, and died. 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

Neurological and digestive disorders are not typically observed with appropriate topical product administration. Product was used before without causing signs, no oral exposure was reported and an appropriate dosage was used. Reported serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. Subsequently ataxia and panting were likely consequences of seizures. Blood in vomit is not anticipated either. Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Cat reported in this case was geriatric with unknown health condition. Time to onset though short for initial reported signs, however is quite long for later reported disorders. Overall, even though no necropsy was performed considering known safety profile of the product and the serious outcome of death product relation is deemed to be unlikely.