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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6658

2. Registrant Information.

Registrant Reference Number: 2016KP204

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-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

07-AUG-16

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. 11556-142

Product Name: k9 advantix II medium dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 07-Aug-2016, a 10 month old, 13.5 pound, neutered,female, Schnauzer (Miniature) canine, in good condition, with a history of seizures, was administered 1 tube of K9 AdvantixII Medium Dog (Imidacloprid-Permethrin-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

Dog / Chien

3. Breed

Miniature Schnauzer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.8

7. Weight (provide a range if necessary )

13.5

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • Gastrointestinal System
    • Symptom - Diarrhea
  • General
    • Symptom - Licking
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Cardiovascular System
    • Symptom - Heart murmur

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

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

Immediately post application, the dog exhibited application site licking that resolved within approximately 1 minute. On 08Aug2016, the dog developed lethargy, anorexia, vomiting, diarrhea, and restlessness. The owner bathed the dog in an unspecified shampoo. On 09Aug2016, the diarrhea resolved. The dog was not examined by a veterinarian and the lethargy, anorexia, vomiting, and restlessness continued. Follow-Up Received (15th Aug 2016): On approximately 10Aug2016, the dog was examined by a veterinarian and was started on subcutaneous lactated ringers solution to be administered by the owner and a bland diet. On 12Aug2016, the dog had 2 seizures. The dog was examined by an emergency veterinarian and administered an unspecified dosage of phenobarbital. The dog was diagnosed a heart murmur and developed cluster seizures. On 13Aug2016, the dog passed away. No necropsy was preformed. 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

Would not expect application site licking directly related to product, however, likely dog scratched at site and caused sign by self-trauma. Pruritus was not reported. Reported vomiting, diarrhoea and restlessness are very unspecific signs and may have potential other causes. Anorexia and lethargy might be a consequence of reported digestive disorders. It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. As dog showed seizures prior to product use, reported seizures and further reported cluster seizures are likely related to this underlying condition. Reported death is not expected either as it is inconsistent with the pharmaco-toxicological product profile. Death is likely a consequence of diagnosed heart murmur. Even though time to onset is short for initial signs, considering long time to onset (5 days and more) for later reported severe and unexpected signs, a product relation is considered unlikely.