Muncie toddler at center of FDA investigation
MUNCIE - An Indiana family is part of an FDA investigation after a voluntary recall of a product that may have caused the death of two infants.
The product is called Simply Thick and it may have led to two surgeries on Muncie girl who nearly died from an intestinal disease.
Nineteen-month-old Hannah Konkle looks like a healthy, happy child. But according to her mother, Pam, the little girl, who was born nine weeks premature, has had severe health problems that the Food and Drug Administration linked to Simply Thick, a food thickening gel.
"She started having a bloated stomach. She stopped stooling and on February 9, we were admitted to Riley Children's Hospital and she subsequently had surgery for a disimpaction," Pam Konkle said.
In May, the FDA recalled several batches of Simply Thick made in a Georgia plant, after two infants died consuming it in their milk. The deaths were caused by a fatal intestinal disease called necrotizing enterocolitis - also known as NEC - found in premature babies. Fifteen other cases are under investigation, including Hannah's.
"It had to be something she was ingesting. It had to be, because we're talking about her bowel. It has to be something she's ingested," Konkle said.
Pam says that Hannah was consuming almost 18 packets of Simply Thick per day when she became ill. The FDA is looking into whether harmful bacteria contaminated several batches during manufacturing. All of these packets in Pam's home are part of the recall.
Pam contacted the FDA after learning of the recall. Within 48 hours, the agency was at her door and now plans on testing her packets for contamination
The FDA says that tests are inconclusive whether Simply Thick causes NEC in children like Hannah. But her parents are worried about a possible link and that other parents may have the recalled product in their home, exposing their children to the same health risk that potentially could have killed their daughter.
According to the manufacturer of Simply Thick, all 15-, 30-, 120- and 240-gram pouches are affected. The recall is limited to products made at a Stone Mountain, Georgia plant.