FDA.reportPublic FDA data

MAUDE MDR 9615909

MDR report key
9615909
Report number
1419937-2020-00003
Event key
0
Event type
3
Date of event
2019-08-20
Date received
2020-01-22
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
JAN KLOIBER
Address
1101 CORPORATE DRIVE MCHENRY IL 60050 US
Phone
800-800-8004
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PUMP BASIC RACK MOBILE VERSIONPUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)MEDELA AGBTA07100010710001NAY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2201. O

Event Narratives#

N

Patient 1

THE DEVICE WAS RETURNED AND EVALUATED ON 11/18/2019 BY MEDELA AG. DURING THE EVALUATION OF THE EXTERIOR OF THE DEVICE, NO DAMAGE OR DEFORMATION WAS NOTED. ADDITIONALLY, THE DEVICE POWERED ON WITHOUT ISSUE AND, DURING A 5 MINUTE RUNNING TEST, THE DEVICE RAN NORMALLY AND WITHIN VACUUM SPECIFICATIONS. REFER TO ATTACHED TEST PROTOCOL. IT IS POSSIBLE THAT THE HOSPITAL USED THE DEVICE INCORRECTLY BECAUSE THE DEVICE HAD BEEN CHECKED WITH THE SERVICE DEPARTMENT AT THE HOSPITAL AND THE PRESSURE WAS CORRECT. THE HOSPITAL CHOSE NOT TO PROVIDE DETAILED INFORMATION; THEREFORE, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE PATIENT'S BACKGROUNDS AND THE DEVICE USAGE/MANAGEMENT METHODS. ADDITIONALLY, THE EXTENT OR CAUSE OF THE INJURIES WAS UNABLE TO BE IDENTIFIED. ALTHOUGH IT CANNOT BE CONFIRMED THAT THE BASIC DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURIES, MEDELA IS FILING THIS REPORT.

D

Patient 1

ON 10/20/2019, A HEALTHCARE PROFESSIONAL FROM CENTRO MEDICO TEKNON ALLEGED TO MEDELA SPAIN THAT IN THE PAST TWO MONTHS, THREE BABIES HAD SUFFERED INJURIES DURING A PROCEDURE USING THE BASIC MEDICAL SUCTION PUMP.