FDA.reportPublic FDA data

MAUDE MDR 9266083

MDR report key
9266083
Report number
0001811755-2019-03599
Event key
0
Event type
3
Date of event
2019-10-16
Date received
2019-11-01
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
MR. ZACH BAKER
Address
4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWN_INSTRUMENTS_PRODUCTTOURNIQUET, PNEUMATICSTRYKER INSTRUMENTS-KALAMAZOOKCYUNK_INSN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-010

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PRESSURE WAS FLUCTUATING DURING A CASE WHERE A STRYKER SMARTPUMP WAS USED AND A STRYKER DISPOSABLE TOURNIQUET CUFF. THE POSSIBLE HARM ASSOCIATED WITH THIS EVENT IS BLOOD LOSS AND IF THIS TYPE OF MALFUNCTION WERE TO REOCCUR DURING A BIER BLOCK PROCEDURE, IT COULD POSE THE RISK OF SYSTEMIC EXPOSURE TO LOCAL ANESTHETIC. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

D

Patient 1

IT WAS REPORTED THAT THE PRESSURE WAS FLUCTUATING DURING A CASE WHERE A STRYKER SMARTPUMP WAS USED AND A STRYKER DISPOSABLE TOURNIQUET CUFF. THE POSSIBLE HARM ASSOCIATED WITH THIS EVENT IS BLOOD LOSS AND IF THIS TYPE OF MALFUNCTION WERE TO REOCCUR DURING A BIER BLOCK PROCEDURE, IT COULD POSE THE RISK OF SYSTEMIC EXPOSURE TO LOCAL ANESTHETIC. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.