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

Catalog Number DUODOPA PEG TUBE

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

Patient Problem No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device manufacturer and lot number of the peg tube involved in this event was not provided by the complainant.Therefore, it is unknown if the tubing involved was the abbvie peg tube.Abbvie has chosen to report this event due to the potential that the peg tube involved could have been the abbvie peg tube.The device involved in the event was not returned; therefore a return sample evaluation is unable to be performed.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, patient in (b)(6) underwent procedure for the placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.The report indicated that the old stoma that does not close completely has gastric leak.On (b)(6) 2020, during endoscopy an internal and an external suture was placed.After two days, the stoma started to drain again with peristomal irritation.

Event Description

Additional information received regarding suture of stoma.The report indicates a suture of the hole with the placement of a mesh was performed under anesthesia.At the moment the stoma is closed without leak.

Manufacturer Narrative

Reference record (b)(4).Additional information added to section b5.

• 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: 10931175
• MDR Text Key: 219127778
• Report Number: 3010757606-2020-00760
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DUODOPA PEG TUBE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PEG TUBE - MANUFACTURER UNK; PEG TUBE - MANUFACTURER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 50