Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1303

2. Registrant Information.

Registrant Reference Number: 2024-US-0025659

Registrant Name (Full Legal Name no abbreviations): Neogen Corporation

Address: 620 Lesher Place

City: Lansing

Prov / State: MI

Country: United States

Postal Code: 48912

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

04-FEB-24

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

30-JAN-24

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 61282-12

Product Name: Ramik Bars

• Active Ingredient(s)
  • DIPHACINONE (PRESENT IN FREE FORM OR AS SODIUM SALT)
    • Guarantee/concentration .005 %

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7. b) Type of formulation.

Bait

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Fever
  • Symptom - Insomnia
  • Specify - Difficulty sleeping

• Nervous and Muscular Systems
  • Symptom - Muscle cramps

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Muscle twitching
  • Specify - Facial twitching

• General
  • Symptom - Pain

• Nervous and Muscular Systems
  • Symptom - Shakiness

• Respiratory System
  • Symptom - Rapid breathing

• Nervous and Muscular Systems
  • Symptom - Confusion
  • Specify - Incoherent

• Cardiovascular System
  • Symptom - Hypotension

• Gastrointestinal System
  • Symptom - Stomach pain
  • Symptom - Abdominal distension

• Renal System
  • Symptom - Renal failure
  • Specify - Renal insufficiency

• Gastrointestinal System
  • Symptom - Other
  • Specify - Diverticulitis

• Liver
  • Symptom - Other
  • Specify - Liver disorder

• Respiratory System
  • Symptom - Pneumonia
  • Symptom - Coughing up blood

• Gastrointestinal System
  • Symptom - Abnormal feces colour

• Cardiovascular System
  • Symptom - Other
  • Specify - Heart failure

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Talking while sleeping
  • Symptom - Aching

• Respiratory System
  • Symptom - Shortness of breath

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Unknown

8. How did exposure occur? (Select all that apply)

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 h

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

On 30-Jan-2024, a 70 year old, 212 pound, male human, with concomitant medical conditions of hypertension, high cholesterol, and depression, was exposed to an unknown amount of Ramik Bars (Diphacinone) via the topical route by the patient. The individual handled bars of product and broke them up using his bare hands. It was unknown how long the individual handled the product and if he washed his hands afterwards. Approximately 8 hours post exposure, the individual developed a fever, nausea, body aches, shakiness, pain in the legs, leg cramps, difficulty sleeping, and facial twitching while sleeping. On approximately 01-Feb-2024, the individual developed talking in his sleep, rapid breathing, shallow breathing, and became incoherent. The individual was transported via ambulance to the emergency room. Upon exam, low blood pressure was noted (90/40). Unspecified labwork was performed that showed the kidneys were not function properly (renal insufficiency). The individual tested negative for the flu, RSV, and Covid. The individual was treated with acetaminophen and hydrocodone / acetaminophen for pain management and ondansetron for the nausea. The blood pressure returned to normal and the patient became coherent again. The individual was released from the emergency room and sent home. On 03-Feb-2024, the individual developed stomach pain. He was evaluated at an urgent care center where x-rays were performed and showed a distended stomach. The individual was referred to an emergency room. While at the emergency room they performed an unspecified scan and diagnosed him with diverticulitis and early stages of heart failure. The individual was treated with an unspecified antibiotic, prescribed antibiotics to continue at home, and discharged. The treating physician did not feel the signs were related to handling the rodenticide product. On approximately 04-Feb-2024, the individual developed dark stools and later that day began coughing up blood. The individual was taken back to the emergency room. A CT scan of the lungs was performed and the individual was diagnosed with pneumonia. Abnormal kidney, liver, and heart function were also noted but improving (as of 06-Feb-2023) since starting antibiotics for the pneumonia. On 07-Feb-2024, a bronchoscopy was performed and no bleeding was noted. The individual currently remained hospitalized receiving unspecified treatments. The clinical signs were improving. The treating physician advised the reporter (individual's wife) that the signs were not related to exposure to the rodenticide. No further information has been received.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Assessment: Long acting anti-coagulants are not well absorbed into systemic circulation through the skin and the described short term dermal exposure is not expected to result in the reported signs and symptoms. The consumer has been diagnosed with diverticulitis, heart failure and pneumonia, in which his doctors believe are the cause of his signs and symptoms. The information provided by the reporter appears reliable and sufficient to confirm the product did not cause the reported adverse event.