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

Catalog Number 062941

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Hernia (2240); No Code Available (3191)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event remained implanted 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 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 21-feb-2019, it was reported that the patient experienced inflammation, suppuration, pain, odor, and infection at the stoma site.The patient was treated with oral levofloxacin 500 mg.For 7 days.

Manufacturer Narrative

Reference record (b)(4).

Event Description

On (b)(6) 2019, it was reported that on an unknown date, the patient was diagnosed with a buried bumper.On (b)(6) 2019, the patient underwent surgery to remove the peg-j tubing.

Manufacturer Narrative

Reference record (b)(4).Additional information added to b5 and h6.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019 it was reported that in august 2019, the patient was diagnosed with a hernia at the site of the previous peg removal surgery for the buried bumper.The hernia appeared as a consequence of the surgery.The patient is scheduled to have a surgical mesh implanted in (b)(6) 2020 and for the time being is using a fastening belt.

• 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: 8395747
• MDR Text Key: 137997956
• Report Number: 3010757606-2019-00140
• 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,Followup
• Report Date: 10/29/2018

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: 11/30/2019
• Device Catalogue Number: 062941
• Device Lot Number: 32253276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 08/01/2019; 10/10/2019
• Supplement Dates FDA Received: 08/13/2019; 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN J-TUBE - LOT # UNKNOWN; UNKNOWN J-TUBE - LOT # UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR