Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-4926
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2017-US0041344
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.
10-JUL-17
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
26-JUN-17
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. 11556-143
Product Name: K9 Advantix II Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
7. b) Type of formulation.
Other (specify)
Spot-on
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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).
A 14 year old, 25 pound, neutered, male, Crossbred Canine, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) 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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Crossbred (Dog)
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
14
7. Weight (provide a range if necessary )
11.34
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Bloody diarrhea
- Symptom - Anorexia
- Nervous and Muscular Systems
- General
- Symptom - Weakness
- Symptom - Death
- Nervous and Muscular Systems
- Symptom - Difficulty getting up
- Specify - unable to stand
12. How long did the symptoms last?
>2 hrs <=8 hrs / > 2 h < = 8 h
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
On approximately 01-Jun-2017, a 14 year old, 25 pound, neutered, male, Crossbred Canine, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.
On approximately 26-Jun-2017 the canine was weak, unable to stand, anorexic and developed bloody diarrhea. The canine was taken to the vet and placed on unknown antibiotics but passed away later that afternoon. No necropsy was performed.
No further information is expected. This case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Reported bloody diarrhoea is not expected even after ingestion, as inconsistent with pharmaco-toxicological product profile. Described sign rather argue for infectious cause or foreign body. Reported weakness and anorexia are rather unspecific and may be consequence of bloody diarrhoea. Though permethrin has the potential to cause slight neurological disorders like unable to stand in particular susceptible animals, time to onset is too long in this case. Thus other causes should be considered. Reported death is not expected either in dog after product application, as inconsistent with pharmaco-toxicological product profile. Geriatric age of the dog and underlying disease should be considered for death. No signs of allergy/anaphylactic reaction reported. Considering all aspects, especially the chronology product connection deemed to be unlikely.