FDA.reportPublic FDA data

MAUDE MDR 6526861

MDR report key
6526861
Report number
1018233-2017-02149
Event key
0
Event type
3
Date of event
2017-03-23
Date received
2017-04-27
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
AMY GRAVLEY
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD? NASOGASTRIC SUMP TUBENG TUBEPRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590BSS0042160NGAW1092* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-2701. H; 2. R

Event Narratives#

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

D

Patient 1

IT WAS REPORTED THAT AFTER THE NASOGASTRIC (NG) TUBE WAS PLACED, THE PATIENT WENT HOME AND THE NG TUBE BECAME DISLODGED THE DAY AFTER. THE PATIENT ALLEGEDLY WENT BACK TO THE HOSPITAL TO HAVE AN ADDITIONAL SURGERY TO REPLACE THE NG TUBE. THE ATTENDING PHYSICIAN BELIEVED THAT THE PORTION OF THE BALLOON WHERE THERE WAS GLUE SEEMED AS IF IT HAD PEELED OFF AND FLIPPED ON ITSELF; DEFLATING THE BALLOON AND CAUSING IT TO FALL OUT.

N

Patient 1

UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS PER ADDITIONAL INFORMATION RECEIVED THE ALLEGED DEVICE IS NOT SOLD BY BARD MEDICAL. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

D

Patient 1

IT WAS REPORTED THAT AFTER THE NASOGASTRIC (NG) TUBE WAS PLACED, THE PATIENT WENT HOME AND THE NG TUBE BECAME DISLODGED THE DAY AFTER. THE PATIENT ALLEGEDLY WENT BACK TO THE HOSPITAL TO HAVE AN ADDITIONAL SURGERY TO REPLACE THE NG TUBE. THE ATTENDING PHYSICIAN BELIEVED THAT THE PORTION OF THE BALLOON WHERE THERE WAS GLUE SEEMED AS IF IT HAD PEELED OFF AND FLIPPED ON ITSELF; DEFLATING THE BALLOON AND CAUSING IT TO FALL OUT.