FDA.reportPublic FDA data

MAUDE MDR 141655

MDR report key
141655
Report number
1047439-1997-00001
Event key
0
Event type
3
Date of event
1997-11-06
Date received
1997-12-29
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#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VISITEC 5192FRONTALIS SUSPENSION PTOSIS SETVISITEC CO.HNM5192*050996K942402NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-12-2901. R

Event Narratives#

D

Patient 1

FRONTALIS SUSPENSION OF THE RIGHT WAS PERFORMED WITH SILICONE ROD ON SUPPLIED PASSING NEEDLES - CARE COMPLETED AND PT TO RECOVERY WITH WELL POSITIONED LID. APPROX 1/2 HR LATER PT NOTED A POPPING IN HER LID AND THE IMMEDIATE DROPPING OF THE LID. SHE WAS TAKEN BACK TO SURGERY AND IT WAS FOUND THAT THE LOOP OF SILICONE HAD BROKEN ON THE MEDIAL LIMB OF THE LOOP NEAR THE LID MARGIN - IT APPEARED TO HAVE JUST FRACTURED. THE WATSKY SLEEVE AND LOCKING STITCH WERE IN PLACE. THE SLING WAS REPLACED WITH ANOTHER SILICONE ROD, AND SHE HAS HAD NO FURTHER SLIPPAGE OR BREAKAGE NOW 5 WK OUT.