FDA.reportPublic FDA data

MAUDE MDR 7809035

MDR report key
7809035
Report number
9612030-2018-02003
Event key
0
Event type
3
Date of event
2018-07-31
Date received
2018-08-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
EDWARD ALMEIDA
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DOBBHOFF 12FR;43IN W/STYLETTUBE, FEEDINGCOVIDIENFPD88847112538884711253703190364X* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-230

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.