Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-4578
2. Registrant Information.
Registrant Reference Number: 2013AM195
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
13-AUG-13
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. 11556-130
Product Name: Advantage II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PYRIPROXYFEN
- Guarantee/concentration 44 %
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).
One vial of Advantage II extra large dog was applied topically by the owner to one spot on the dorsal midline.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic short hair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
13
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- Cardiovascular System
- Symptom - Other
- Specify - enlarged heart
- Respiratory System
- Symptom - Other
- Specify - fluid filled lungs
- Liver
- Symptom - Other
- Specify - blood clots around the liver
- General
- Symptom - Other
- Specify - hypertrophy on left side
- Respiratory System
- Symptom - Other
- Specify - abundance of foam in the trachea
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
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 26Apr2013, a 12 year old, 13 pound, spayed, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered an unknown amount of Advantage II Extra Large Dog (Imidacloprid- Pyriproxyfen) once topically by the owner. This is an off label usage of the product; the product is not intended for use on cats. The patient is an outdoor cat. The morning of 29Apr2013 the patient was found deceased. The attending veterinarian performed a gross necropsy and the patient was noted to have an enlarged heart, and fluid filled lungs, blood clots around the liver, hypertrophy on the left side and an abundance of foam in the trachea.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Intended misused direct topical dermal exposure of the product to the cat. Exposed site is inconsistent with affected site. Sudden death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Time to onset (3 days) too long. 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. No signs of allergy or anaphylaxis reported. Other causes more likely. Necropsy revealed underlying heart disease. Considering this, a product relation is considered unlikely.