DUODOPA_DUOPA 062941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-26 for DUODOPA_DUOPA 062941 manufactured by Abbvie - Medical Device Center.

Event Text Entries

[186716608] Reference number (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 in the patient and was not returned; therefore, a return sample evaluation is unable to be performed. Per the instructions for use (ifu): to secure the peg tube, the peg tube should be pulled until elastic resistance is felt, keep under tension, secure fixation plate into position using the clip, and remain under moderate tension for 24-72 hours to promote good adherence to the stomach wall to the inner abdominal wall. A pneumoperitoneum is a known complication of a peg tube/ j-tube placement. (b)(4). If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[186716609] On (b)(6) 2020, 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) 2020, the patient experienced stinging pains in the abdomen. Computer tomography and ekg examinations were performed and a pneumoperitoneum was found. The patient was treated with unknown antibiotics. The pneumoperitoneum was resolving.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010757606-2020-00213
MDR Report Key9886589
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-03-26
Date of Report2020-03-04
Date of Event2020-03-02
Date Mfgr Received2020-03-04
Device Manufacturer Date2018-07-31
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TERRY INGRAM
Manufacturer Street1675 LAKESIDE DRIVE
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8479385350
Manufacturer G1ABBVIE - MEDICAL DEVICE CENTER
Manufacturer Street1675 LAKESIDE DRIVE
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal Code60085
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDUODOPA_DUOPA
Generic NameTUBES, GASTROINTESTINAL (AND ACCESSORIES)
Product CodeKNT
Date Received2020-03-26
Catalog Number062941
Lot Number32312218
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBVIE - MEDICAL DEVICE CENTER
Manufacturer Address1675 LAKESIDE DRIVE WAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-26

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