Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-1572
2. Registrant Information.
Registrant Reference Number: 2013AM063 - US0009781
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.
12-DEC-12
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
12-DEC-12
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.
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- 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).
On Dec. 12,2012, a 6 year old, 11.8 pound, spayed, female, domestic medium hair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog once 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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
DMH
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
11.8
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
Unknown
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 twelve hours following the off label administration of product the cat was found seizing. The cat presented to the veterinarian and the cat was anesthetized with isofluorane, an intravenous catheter was placed and intravenous fluids given. During the attempt to transfer this cat to a specialty hospital the cat went into cardiac arrest. Cardiopulmonary resusitation was unsuccessful and the cat died. No necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Neurological signs and onset time are consistent with permethrin toxicity following direct product use on cat. Vet anesthetized cat with isofluorane and intravenous fluids were given. During transport to clinic cat went into cardiac arrest and died. However, even though permethrin is toxic for cats and may have a fatal outcome, generally cats have a good chance to recover if adequate treatment is applied in time.