New incident report
Incident Report Number: 2022-3664
Registrant Reference Number: 2022-US-016979
Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation
Address: 400 Plaza Drive
City: Secaucus
Prov / State: New Jersey
Country: USA
Postal Code: 07094-3688
Domestic Animal
Country: UNITED STATES
Prov / State: GEORGIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 2596-168
Product Name: Hartz UltraGuard Dual Action Topical Flea and Tick Prevention for Dogs
PMRA Registration No. PMRA Submission No. EPA Registration No. 2596-153
Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Dog / Chien
Great Pyrenees/Poodle - Standard crossbred
1
Female
1
55
lbs
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 21-May-2022, a 1 year old, 55 pound, non-pregnant non-lactating, female, Great Pyrenees/Poodle - Standard crossbred dog, in unknown condition, with no known concomitant medical condition, the dog was administered an unknown amount of Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs (Phenothrin (Sumithrin)) via the topical route by the animal owner. On 22-May-2022, the dog was administered 1 tube of Hartz UltraGuard Dual Action Topical Flea and Tick Prevention for Dogs and Puppies 31-60 lb (Etofenprox / N-Octyl-Bicycloheptene Dicarboximide (MGK-264) / Piperonyl Butoxide / Pyriproxifen (Nylar)) via the topical route by the animal owner. This was extra label use as both products were administered within approximately a 24 hour period. Approximately four hours post-application of the Hartz UltraGuard Dual Action Topical Flea and Tick Prevention for Dogs and Puppies, the dog developed lethargy and was walking slowly. Approximately eight hours post product administration, the dog was found deceased in her crate and was buried that same day. No further information was received.
Death
Assessment: Both products have a wide margin of safety when applied per label directions in dogs. Both are poorly absorbed across intact skin and systemic effects are not expected. Lethargy is possible especially after use of the spot-on product, potentially due to a paresthesia response, or if the dog does not like the feeling of the wet product on its skin. Without a necropsy, the cause of death is unknown, but other causes including infectious disease, foreign body obstruction, underlying cardiac disease, and toxin exposure should be considered. The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.