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

Catalog Number 062943

Device Problem Insufficient Information (3190)

Patient Problem Ulcer (2274)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog number is the international list number which is similar to us list number of 062918.Device is expected to be returned for evaluation, however it has not been received yet.Upon receipt the sample will be evaluated and a follow up will be submitted.A gastric ulcer 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) 2017, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, a gastroscopy was performed, and an ulcer was observed in the pylorus.The intestinal tube was removed on (b)(6) 2019, and the patient was treated with pariet 20 mg.And madopar 200 + 50 mg.

Manufacturer Narrative

Reference record (b)(4).The j-tube attached to click adaptor was received.The j-tube was returned without the bolus.During the visual inspection of the sample, no damages or defects were observed.A gastrointestinal ulcer is a known complication of use of the device.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

The sample was returned and evaluated.

• 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: 8693838
• MDR Text Key: 147846415
• Report Number: 3010757606-2019-00390
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142816
• 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: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 062943
• Device Lot Number: 32084207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBVIE PEG TUBE - LOT # 32065306.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR