FDA.reportPublic FDA data

MAUDE MDR 576467

MDR report key
576467
Report number
MW1034705
Event key
0
Event type
3
Date of event
2002-10-28
Date received
2005-02-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*IDETUNKISRUNKUNKUNKNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-02-2201. S

Event Narratives#

D

Patient 1

PT HAS BEEN WEARING A SUPPORT BELT FOR A BACK PROBLEM SINCE 2001. THE SUPPORT BELT COLLAPSED AND PT UNDERWENT FUSION OF THE DISC. SURGERY DID NOT HOLD AND PT WAS ON DEMEROL FOR PAIN THE INTENSITY OF THE PAIN INCREASED AND PT COULD NOT WALK ALONE EXCEPT WITH CRUTCHES. PT WAS BENT OVER. PT WAS GIVEN A BLOCKING INJECTION AND LATER DEVELOPED TARLOV CYST. REFERRED TO ANOTHER FACILITY.