FDA Adverse Event Injury Summary report: N

DUODOPA_DUOPA

MDR report key: 21047492 · Received December 31, 2024

Report

Report Number: 3010757606-2024-10268
Event Type: Injury
Date Received: December 31, 2024
Date of Event: December 3, 2024
Report Date: December 31, 2024
Manufacturer: ABBVIE - MEDICAL DEVICE CENTER
Product Code: KNT
PMA / PMN Number: K142793
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

REFERENCE NUMBER: (B)(4). CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062910. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. STOMA SITE INFECTION IS A KNOWN COMPLICATION OF A PEG- J TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 0

ON (B)(6) 2024, A PATIENT IN SPAIN UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY-JEJUNAL (PEG-J) TUBES. ON (B)(6) 2024, IT WAS REPORTED THE PATIENT HAD DEVELOPED A STOMA INFECTION ON (B)(6) 2024. A CULTURE WAS PERFORMED AND A REGIMEN OF ORAL ANTIBIOTIC AMOXICILLIN/CLAVULANIC ACID 850/125 EVERY 8 HOURS WAS PRESCRIBED. THE STOMA WAS SLIGHTLY REDDENED, WITH PURULENT EXUDATE AND A POSSIBLE LAYER OF SCALY SKIN. ADVANCED PRACTICE NURSE REPORTS THAT THE STOMA HAS EVOLVED FOR THE BETTER. TO TREAT WITH SOAP AND WATER TO CLEAN AND APPLICATION OF FURACIN OINTMENT TWICE A DAY FOR 10 DAYS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1088664	DUODOPA_DUOPA	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	KNT	ABBVIE - MEDICAL DEVICE CENTER		32031402

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR	Male	Required Intervention	INTESTINAL TUBE/ LOT#: 32481342.