MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062945

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

Patient Problems Fistula (1862); Inflammation (1932)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062912.The device involved in the event was not returned; therefore a return sample evaluation was not performed.Gastrointestinal perforation is a labeled known event.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, patient in (b)(6) underwent procedure for placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.On (b)(6) 2020, it was reported that, nurse visited the patient for abdominal pain and stoma care was performed.The patient had been visited by a gastroenterologist two months ago and suggested to have tubing replacement.It was recommended for pain to visit an on-call hospital.Additional information received on (b)(6) 2020.It was reported that the patient had stoma site inflammation externally and internally with malodorous discharge.On (b)(6) 2020 the patient underwent gastroscopy, stoma culture and ct of the abdomen.Report indicated that a fistula was found in left transverse colon and from the culture obtained, it was found that there is stool outflow from the stomach.The peg-j tube was removed.According to the surgeon, the bowel was eroded by a hard object and does not know if it was due to the tubings.Additional information indicated that on (b)(6) 2020 surgery was performed on the patient, and a part of the patient's stomach and intestine were removed.The surgery went well.Patient was treated with iv antibiotics flagyl and cefoxitin three times a day.The patient was discharged on (b)(6) 2020.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer (Section G): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer Contact: terry ingram ; 1675 lakeside drive; waukegan, IL 60085 ; 8479385350
• MDR Report Key: 9891865
• MDR Text Key: 186716933
• Report Number: 3010757606-2020-00219
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 062945
• Device Lot Number: 32384386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 60