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); Insufficient Information (3190); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Abscess (1690); Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)

Event Date 08/01/2019

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.It was unknown if the device involved in the event remained implanted in the patient or was discarded; therefore, a return sample evaluation is unable to be performed.Stoma site infection and buried bumper are known complications of a peg 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 sweden underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.Beginning in (b)(6) 2019, the patient experienced repeated stoma site infections which were treated with unknown oral antibiotics.On (b)(6) 2019, during a peg-j tube replacement due to the repeated stoma infections, the surgeon discovered a buried bumper.The patient was subsequently hospitalized.The buried bumper site had an abscess that was leaking pus.The stoma site was dilated to about 2 cm.In diameter with about 10 cm.Of redness around the stoma.The physician suspected a colony of bacteria at the stoma site and did not insert new peg-j tubing.It was unknown if the peg-j tubing was removed at the time the buried bumper was discovered.

Manufacturer Narrative

Reference record (b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, the patient had surgery to removed the peg-j tubing due to the buried bumper.On (b)(6) 2019, the patient experienced a fever, was diagnosed with sepsis, and subsequently hospitalized.On (b)(6) 2019, a culture exam from the stoma showed candida growth.The sepsis was treated with oral cefotaxim and amoxicillin.The sepsis subsequently resolved, and on (b)(6) 2019, the patient was discharged from the hospital.

• 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: 8966570
• MDR Text Key: 156661047
• Report Number: 3010757606-2019-00601
• 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: 08/13/2019

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: Lay User/Patient
• Device Catalogue Number: 062941
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 10/11/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR