MAUDE Adverse Event Report: PEG FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Electrolyte Imbalance (2196); Hypernatremia (2242)

Event Date 04/01/2023

Event Type  Injury  

Event Description

Hypernatremia; hypermagnesemia; anorectal infection; anemia.Patient completed cisplatin per protocol on (b)(6) 2023 and radiation per protocol on (b)(6) 2023.He was scheduled for labs and hydration on (b)(6) 2023.His labs revealed a sodium of 177 and magnesium of 3.5.Patient did report weakness and dizziness.Patient was advised to go to the emergency room and he was admitted to (b)(6) hospital.Dr.(b)(6) aware of his admission.He feels that it is unlikely to be related to cisplatin, most likely d/t peg tube feeding and not receiving enough water.\while patient was hospitalized on (b)(6) 2023; patient was having rectal bleeding and found to have an anorectal infection and had the rectal lesion drained at the bedside and placed on iv antibiotics.Also, because of the rectal bleeding and upper gastrointestinal hemorrhage grade 2; patient had a hemoglobin of 7.9.Dr.(b)(6) aware of these aes on 4/7/2023.Patient remains hospitalized on (b)(6) 2023.Pt was discharged from the hosp to home in stable condition.His hypernatremia resolved on (b)(6) 2023.

• Brand Name: PEG FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 16790951
• MDR Text Key: 313849453
• Report Number: MW5116908
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: CISPLATIN: 40MGJ/M2 IV QW FOR 7 WEEKS
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 72 KG