NEOMED ENTERAL FEEDING TUBE PFTM8.0P-EO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-15 for NEOMED ENTERAL FEEDING TUBE PFTM8.0P-EO manufactured by Neomed, Inc.

Event Text Entries

[141951328] This report is in response to medwatch user facility report # (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[141951329] Gastric perforation was identified in a sextuplet nicu patient (patient identifier: (b)(6)) after signs and symptoms of abdominal distention. Gastric perforation was identified and corrected in surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006520777-2019-00003
MDR Report Key8514521
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-04-15
Date of Report2019-04-15
Date of Event2019-03-16
Date Mfgr Received2019-03-19
Device Manufacturer Date2018-08-25
Date Added to Maude2019-04-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. MELINDA SMITH
Manufacturer Street100 LONDONDERRY COURT SUITE 112
Manufacturer CityWOODSTOCK GA 30188
Manufacturer CountryUS
Manufacturer Postal30188
Manufacturer Phone7704855188
Manufacturer G1SYNECCO, CO., LTD.
Manufacturer StreetB801 RONGAN PLAZA NO. 700 SOUTH TIANTONG ROAD
Manufacturer CityNINGBO, YINZHOU DISTRICT 315100
Manufacturer CountryCH
Manufacturer Postal Code315100
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEOMED ENTERAL FEEDING TUBE
Generic NameTUBE, FEEDING
Product CodeFPD
Date Received2019-04-15
Model NumberPFTM8.0P-EO
Catalog NumberPFTM8.0P-EO
Lot Number20180825
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNEOMED, INC
Manufacturer Address100 LONDONDERRY COURT SUITE 112 WOODSTOCK GA 30188 US 30188


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-04-15

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