DOBBHOFF 12FR;43IN W/STYLET 8884711253

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-23 for DOBBHOFF 12FR;43IN W/STYLET 8884711253 manufactured by Covidien.

Event Text Entries

[117998381] The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10


[117998382] The customer reported that the device has its entry too wide and therefore it does not adhere well, causing leaks of the diet and water. Also, the device gets obstructed easily even after the washing technique was used.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612030-2018-02003
MDR Report Key7809035
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-08-23
Date of Report2018-08-23
Date of Event2018-07-31
Date Mfgr Received2018-08-08
Date Added to Maude2018-08-23
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 ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD IND
Manufacturer CityTIJUANA 22500
Manufacturer CountryMX
Manufacturer Postal Code22500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDOBBHOFF 12FR;43IN W/STYLET
Generic NameTUBE, FEEDING
Product CodeFPD
Date Received2018-08-23
Model Number8884711253
Catalog Number8884711253
Lot Number703190364X
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-23

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