New incident report
Incident Report Number: 2018-1062
Registrant Reference Number: 2018RB002
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: CANADA
Prov / State: NEWFOUNDLAND
PMRA Registration No. 27584 PMRA Submission No. EPA Registration No.
Product Name: advantage II extra large dog
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Boxer (German Boxer)
1
Male
7.5
46.8
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 hrs <=8 hrs / > 2 h < = 8 h
System
Unknown / Inconnu
No
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 5-6 hours after application the dog developed a burn around his mouth. The pet owner suspects the dog came in contact with the product near his mouth. The area is healing but he has not fully recovered at this time. Note. Additional information from Duplicate case CAN-BAYERBAH-2018-CA0000001 (Report 466798): On 08-Jan-2018, a 7.5 year old, 105 pound, neutered, male, Boxer canine, in unknown condition, with concomitant medical conditions of fleas and pruritus, was administered 1 tube of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) topically by the owner. Approximately 6 hours post application, the dog exhibited a skin lesion just below the nose and panting. The dog was not examined by a veterinarian and the clinical sign continued. Product was Advantage II XL
Minor
B - Possible Skin reactions on other than the application site are not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Panting is not expected with appropriate topical product use and may rather be a behavioural reaction to product sensation than a sign of respiratory illness. Considering short time to onset, a product relation is considered possible.