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U.S. Department of Health and Human Services

Case Study 3 – Medical Food

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Jennifer R., a female African-American newborn, was born on March 24 after an uneventful pregnancy for her mother and an uneventful delivery. In the first few days after her birth, Jennifer required treatment for retrocardiac pneumonia, associated with hypoxia with a history of wheezing. She also was susceptible to aspiration of her formula and a diagnosis of gastroesophageal reflux disease (GERD) was made when she was about 2 weeks old.

XYZ Pharmaceutical’s thickening agent was started for the GERD on April 13. The dosage was a 4-ounce packet with every feeding. Jennifer was discharged from the hospital and continued on the product at the same dosage until it was discontinued on May 4. Jennifer’s mother noticed she had bloody diarrhea on May 9 and took her to the emergency room. Jennifer required hospitalization and a gastrointestinal (GI) workup which confirmed the diagnosis of necrotizing enterocolitis. Jennifer underwent a small bowel resection and the GI symptoms resolved completely over the next 10-14 days. Jennifer was discharged and she remains in good health.

A. Patient Information


3. Sex

4. Weight

or

B. Adverse Effects, Product Problem or Error

1. Check all that apply: (?HelpUseful TipThe HIPAA Privacy Rule specifically permits pharmacists, physicians, nurses, or hospitals (i.e. covered entities) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.)


C. Product Availability

Product Available for Evaluation? (Do not send product to FDA)

D. Suspect Product(s)

E. Suspect Device


5. Operator of Device


8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?

F. Other (Concomitant) Medical Products

G. Reporter



2. Health Professional?
4. Also Reported to:
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