New incident report
Incident Report Number: 2024-2054
Registrant Reference Number: 2024-CA-000162
Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation
Address: 200 Plaza Drive, Suite 402
City: Secaucus
Prov / State: New Jersey
Country: USA
Postal Code: 07094
Domestic Animal
Country: CANADA
Prov / State: ONTARIO
PMRA Registration No. 30732 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Flea and Tick Drops for Dogs 2.5 - 6 kg
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Terrier - West Highland White/Shih Tzu crossbred
1
Female
14
2.6
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 hrs <=8 hrs / > 2 h < = 8 h
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 07-Apr-2024, a 14 year old, approximately 2.6 kilogram, neutered, female, Terrier - West Highland White/Shih Tzu crossbred dog, in unknown condition, with concomitant medical conditions of arthritis and anxiety, was administered1 tube of Hartz UltraGuard Flea and Tick Drops for Dogs 2.5 - 6 kg (Phenothrin (Sumithrin)) via the topical route by the animal owner. The dog was concurrently administered gabapentin at an unspecified dose and frequency, via an unknown route by the animal owner. Approximately 4 hours post application, the dog developed lethargy. On 08-Apr-2024, the dog developed anorexia, rapid breathing, and several episodes of vomiting. On 10-Apr-2024, the dog was evaluated by a veterinarian. Multiple diagnostics were performed including chest radiographs, a complete blood count, and an unspecified chemistry panel. Fluid in the lungs (pumonary edema) was detected and the dog was diagnosed with congestive heart failure. The dog was sent home and administered pimobendan and furosemide (unspecified doses and routes) by the animal owner, as directed by the veterinarian. The clinical signs were significantly improved by 13-Apr-2024. On 16-Apr-2024, the rapid breathing worsened. The animal owner consulted with the veterinarian over the phone and was instructed to administer another dose of furosemide. The dog died later that evening. The veterinarian reported to the animal owner that the dog's clinical signs, diagnoses and death were unrelated to the product but were due to diagnosed congestive heart failure. The dog had also been administered the product monthly, March - November, since approximately 01-Mar-2019. Approximately 4 hours after each monthly application the dog developed mild lethargy that lasted approximately 24 hours, then resolved without treatment. No further information is expected.
Death
Assessment: This product has a wide margin of safety in dogs and was used numerous times on this dog without incident. Development of congestive heart failure does not fit the toxicological profile of the product. The treating veterinarian also informed the owner that development of heart failure and subsequently death was not related to product use. Congestive heart failure is a relatively common condition in older dogs and often related to degenerative mitral valve disease, especially in smaller breeds. 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.