Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2727
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0031803 (Report 498041)
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.
19-JUN-18
5. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
6. Date incident was first observed.
17-JUN-18
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: K9advantixII extra 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.
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 14-Jun-2018, a 7 year old, 95 pound, neutered, male, Retriever Labrador (No Description) crossbred canine, in unknown condition, with a concomitant medical history of seizures, was administered 1 tube of K9 Advantix II Extra 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 (Retriever Labrador x)
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
43.09
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Inappropriate defecation
- Nervous and Muscular Systems
- General
- Symptom - Neoplasia
- Symptom - Death
- Gastrointestinal System
- Symptom - Salivating excessively
- Nervous and Muscular Systems
- General
- Symptom - Abnormal behaviour
- Symptom - Other
- Specify - Stiffness NOS
- Renal System
- Symptom - Inappropriate urination
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
No
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 17-Jun-2018, the dog exhibited intermittent seizures, hypersalivation, inappropriate urination, inappropriate defecation, lateral recumbency, paddling, stiffening, a thrashing behavior (behavioral disorder NOS) and dyspnea.
On 19-Jun-2018, the clinical signs resolved without medical intervention.
On approximately 21Jun2018, the canine was diagnosed with a brain tumor and died. It was unknown if a 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
N - Unlikely
It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. As dog showed seizures prior to product use, seizures are likely related to this underlying condition. Hypersalivation, inappropriate urination, inappropriate defecation, lateral recumbency, paddling, stiffening, thrashing behaviour and dyspnea may be associated to reported seizure. Brain tumor and death is not expected after topical product application as it is inconsistent with pharmaco-toxicological product profile. Product has no carcinogenic potential. Other causes are more probable. Death is likely a consequence of diagnosed brain tumour. Finally, though necropsy details are unknown, considering the known product profile and long time to onset (3 days and more), and diagnosed brain tumor, sufficient information exists to conclude that the product did not cause the event and a product connection is deemed to be unlikely.