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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3539

2. Registrant Information.

Registrant Reference Number: 2016KP022

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.

04-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

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 - unknown

  • 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.

.4

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 an unknown date in 2013, an approximately 14 year old,Unknown Terrier canine, of unknown weight, reproductive status, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II(dog-unspecified) (Imidacloprid-Pyriproxyfen) topically 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Unknown terrier

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

Unknown

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
  • Eye
    • Symptom - Blindness (permanent)
  • Ear
    • Symptom - Hearing loss
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Musculoskeletal disorder
  • Gastrointestinal System
    • Symptom - Anorexia

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.

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 administration, the canine was lethargic. Approximately 2 days post administration, the canine recovered. The canine was switched to an spinosad by mouth product monthly. An unknown time post administration of K9 Advantix II in 2013, the canine became blind, deaf, nonambulatory, anorexic, and died. It is unknown if the canine was euthanized or if a necropsy was performed. No further information is expected. This case is closed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss another pet and was not to report the death of the patient. Follow up information received on 2nd Feb 2016 : On an unknown date in 2013, an approximately 14 year old, Unknown Terrier canine, of unknown weight, reproductive status, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. Immediately post administration, the canine was lethargic. Approximately 2 days post administration, the canine recovered. The canine was switched to an oral spinosad product that was administered monthly for an unknown duration. An unknown time post administration of Advantage II dog unspecified, the canine became blind, deaf, nonambulatory, anorexic, and died. It is unknown if the canine was euthanized or if a necropsy was performed. No further information is expected. This case is closed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss another pet and was not to report the death of the patient.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Lethargy is an unspecific sign and may have multiple potential other causes in an animal. All other reported signs such as musculoskeletal, eye and ear disorders, anorexia and fetal outcome death are not expected after topical product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergy/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 3 years). Additionally, the reason for the initial call to Bayer was to discuss another pet and was not to report the death of this geriatric patient. Overall, even though some information is missing (e.g. necropsy details and time to onset), considering the known safety profile of the product, product relation is unlikely.