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

Catalog Number 062943

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

Patient Problem Bowel Perforation (2668)

Event Date 02/07/2022

Event Type  Injury  

Event Description

On an unknown date, a patient in netherlands underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, the patient was hospitalized due to a small intestinal perforation caused by the intestinal tube.It was unknown if the j-tube was removed or what interventions the patient received for the perforation.

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The disposition of the device involved in the event was unknown; therefore, a return sample evaluation is unable to be performed.Intestinal perforation is a known complication of a j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The disposition of the device involved in the event was unknown; therefore, a return sample evaluation is unable to be performed.Intestinal perforation is a known complication of a j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in netherlands underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, the patient was hospitalized due to a small intestinal perforation caused by the intestinal tube.It was unknown if the j-tube was removed or what interventions the patient received for the perforation.

• 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: 13621770
• MDR Text Key: 286266476
• Report Number: 3010757606-2022-00122
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2022

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: 10/31/2019
• Device Catalogue Number: 062943
• Device Lot Number: 32183216
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• 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
• Treatment: PEG TUBE - UNKNOWN MANUFACTURER AND LOT #
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male