FDA.reportPublic FDA data

MAUDE MDR 1571644

MDR report key
1571644
Report number
2182979-2009-00004
Event key
0
Event type
3
Date received
2009-12-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ERIC CAILLE
Address
1500 PARK RD CHANHASSEN MN 55317 US
Phone
952-952-9524
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PMT HALO VESTHALOPMT CORPILZ1233-5090909Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-12-1001. R

Event Narratives#

D

Patient 1

CUSTOMER REPORTED THAT A PT THAT WAS WHEELCHAIR BOUND WAS WEARING A PMT HALO, THE CARDIAC CREASE ON THE HALO CRACKED. CAUSING THE VEST TO BREAK AT THE CREASE. A NEW FRONT PIECE WAS ORDERED AND PLACED ON THE PT. NO SERIOUS HARM OR INJURY OCCURRED TO THE PT.

N

Patient 1

AS THE PT WAS WHEELCHAIR BOUND, ADDED STRESS TO THE FRONT PORTION OF THE VEST WAS INEVITABLE. THE HEALTH PROFESSIONAL SHOULD HAVE ORDERED A CUSTOM VEST TO ENSURE THAT THE FIT OF THE HALO VEST WAS APPROPRIATE TO THE SITUATION.