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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3589

2. Registrant Information.

Registrant Reference Number: 2015KP006

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. 11556-117

Product Name: advantage 10

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

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 approximately 2001, an approximately 4.5 year old, 5 pound, neutered, female,Yorkshire Terrier canine, in unknown condition, with no knownconcomitant medical conditions, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) 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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Blister

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Approximately 3 hours post application, the dog developed application site blisters. She was examined by a veterinarian, bathed in an unspecified shampoo, and started on an unspecified topical ointment. Approximately 1 week post application, the dog recovered. On an unknown date in 2011, the dog passed away from an unknown cause. It is unknown if a necropsy was performed. The reporting party was not calling to report the death of the patient but had questions about another Bayer product. No further information expected. Case closed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Application site blisters are not expected; Maybe animal scratched at site and caused sign by self-trauma. Time to onset short for this sign. Death is not expected after product application, as inconsistent with pharmacotoxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. A 20-fold overdosage tolerated by dogs without showing any side effect. The dog was geriatric. Moreover, reporting party didn't call to report the death of the patient but to ask questions about another Bayer product. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Time to onset is exceptionally long (10 years). Even though no necropsy was performed, sufficient information exists to rule out product relation completely. Thus, a product relation is unlikely.