Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-1439
2. Registrant Information.
Registrant Reference Number: 2013AM025 - 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.
17-OCT-12
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
17-OCT-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. 11556-144
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 Oct.17, 2012, an 8 year old, 55 pound, intact, female, Bulldog canine, in good condition, with a current flea infestation, 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
Dog / Chien
3. Breed
Bulldog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
55
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>2 hrs <=8 hrs / >2 h <=8 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Renal System
- Symptom - Lack of control of urination
- Nervous and Muscular Systems
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?
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
A few hours post application the dog was lethargic, ataxic, panting, and had loss of bladder control. 12 hours post application the dog passed away due to unknown causes. The dog was not seen or treated by a veterinarian.
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 rather unspecific sign and may occur in particular sensitive dogs. Even though more expected after oral ingestion, Permethrin has the potential to cause slight neurological disorder. Panting and Urinary incontinence are not expected. Death is not expected, as inconsistent with product profile. Other etiologies are more probable. Technical evaluation - The complaint batch was manufactured and released according to specifications.