MAUDE MDR 49454

MDR report key
49454
Report number
1932180-1996-00107
Event key
0
Event type
3
Date of event
1996-10-17
Date received
1996-11-14
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
1STORZ LEIVERS MOUTH GAG FRAME, CHILD SIZEMOUTH GAGSTORZ INSTRUMENT CO.KBNNAN7451NANYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11996-11-140

Event Narratives#

D

Patient 1

DURING A TONSILLECTOMY, THE THUMB LATCH SPRING WAS CRACKED. THE PROCEDURE WAS DELAYED LONG ENOUGH TO SWITCH TO A DIFFERENT INSTRUMENT.