New incident report
Incident Report Number: 2017-0688
Registrant Reference Number: 2017KP010a
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: advantage II large cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Longhair
1
Male
5.5
11
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 13 Oct 2016, the pruritus and skin lesions worsened. The cat was not examined by a veterinarian and the clinical signs continued. Follow up received on 7th Nov 2016: On 13 Oct 2016, the pruritus and skin lesions worsened. The cat was not examined by a veterinarian and the clinical signs continued. The owner administered another tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. This was again, an off label use of the product as it was a low dose for this cat. The clinical signs continued. On 05 Nov 2016, the cat was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. Approximately 30 minutes post application, the cat vocalized and died. The cat was examined by a veterinarian and pronounced dead on arrival. No necropsy was performed.
Death
Pruritus and skin lesions are reported prior to product application, hence not related to the product. Vocalization is an unspecific sign and may have numerous other causes. Death is not expected after product application as inconsistent with pharmaco-toxicological product profile. Other causes should be considered. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Animal involved in this case was in poor health condition, which may have further contributed to death of the animal. Product was well tolerated to previous application of the product. However, considering short time to onset and no necropsy was performed, a product connection is unassessable.