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

Catalog Number 062941

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

Patient Problems Anemia (1706); Hematoma (1884); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Reference number (b)(4).Catalog number is the international list number which is similar to us list number of (b)(4).The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Buried bumper 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.

Event Description

On (b)(6) 2019, a patient in spain underwent a procedure for the replacement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After an unspecified amount of time, the patient experienced difficulty mobilizing the peg tube and a buried bumper was diagnosed.

Manufacturer Narrative

Reference record (b)(4).

Event Description

After an unspecified amount of time, the patient suffered a complication after laparoscopy, an operation performed to remove the buried bumper.After a day of resuscitation, the patient experienced anemia, urgent ct scans were performed and abdominal hematoma was checked for dehiscence of gastric suture.They intervened again by open surgery.The patient was currently in icu, hemodynamically stable.On (b)(6) 2019, it was reported that the patient was still hospitalized, his condition was optimal.The surgical wound was infected for two days and received an intravenous antibiotic.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 9205467
• MDR Text Key: 163015557
• Report Number: 3010757606-2019-00729
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 062941
• Device Lot Number: 32384356
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBVIE J TUBE, LOT # 32344336.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR