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 Death (1802); Perforation (2001)

Event Date 05/08/2020

Event Type  Death  

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 was not returned; therefore a return sample evaluation is unable to be performed.Gastrointestinal perforation 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, patient in (b)(6) underwent procedure for replacement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.Wife reported that in may 2020, the tube perforated the intestine and his health condition was complicated.On (b)(6) 2020, the patient passed away.The cause of death was reported as gastric perforation and tip of peg tube inside peritoneum.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer (Section G): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer Contact: terry ingram ; 1675 lakeside drive; waukegan, IL 60085 ; 8479385350
• MDR Report Key: 10236548
• MDR Text Key: 197681946
• Report Number: 3010757606-2020-00417
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 062941
• Device Lot Number: 32064207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBVIE J TUBE BATCH NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 51