DUODOPA_DUOPA 062941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-03-23 for DUODOPA_DUOPA 062941 manufactured by Abbvie - Medical Device Center.

Event Text Entries

[184484772] Reference record (b)(4). Catalog number 062941-001 is the international list number which meets the requirements of the similar product listed which is the us list number. The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed. Pneumoperitoneum, stoma site infection, and gastric / bowel perforation are known complications of a peg tube placement. If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[184484773] 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. The spouse reported that the patient remained hospitalized due stoma site pain. The patient was found to have a pneumoperitoneum. The patient was also found to have a stoma infection which was treated with 500mg of cefuroxime every 12 hours. On (b)(6) 2020 the patient was discharged but still had pain. The patient had no symptoms of an infection but stoma irritation. The spouse reported that the event of stoma pain was due to post peg placement of pneumoperitoneum and the peg tube was removed on an unknown date. On (b)(6) 2020, the patient was admitted to the hospital with a gastric perforation and died. It was unknown if an autopsy was performed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010757606-2020-00203
MDR Report Key9866125
Report SourceCONSUMER,FOREIGN,OTHER
Date Received2020-03-23
Date of Report2020-02-25
Date of Event2020-02-20
Date Mfgr Received2020-02-25
Device Manufacturer Date2018-05-11
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 Received2020-03-23
Catalog Number062941
Lot Number32195288
OperatorLAY USER/PATIENT
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. Hospitalization; 2. Other; 3. Required No Informationntervention 2020-03-23

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