FDA.reportPublic FDA data

MAUDE MDR 900476

MDR report key
900476
Report number
900476
Event key
0
Event type
3
Date of event
2007-07-05
Date received
2007-07-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PAPETTECELL COLLECTOR, CERVICALWALLACH SURGICAL DEVICES, INC.HHT**12X1NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-07-060

Event Narratives#

D

Patient 1

THE MD WAS PERFORMING A PAP SMEAR WITH A PAPETTE BRUSH. AS HE WAS REMOVING THE DEVICE, THE WHITE BRUSH TIP CAME OFF OF THE HANDLE AND FELL INTO THE VAGINAL CANAL. THE RN WENT TO THE ED TO OBTAIN A PAIR OF FORCEPS SO THAT THE MD COULD REMOVE THE BRUSH. THE PATIENT WAS NOT INJURED. THE MD IS EXPERIENCED IN USING THIS DEVICE & HAS NOT HAD THIS HAPPEN BEFORE. THE BRUSH WAS NOT FORCED INTO THE CERVICAL OS AND THE MD HAD NO DIFFICULTY USING THE DEVICE. THE MD DISCARDED THE DEVICE; HOWEVER, THE BAG FROM WHICH THIS DEVICE CAME WAS CHECKED. OF THE SIX PAPETTES REMAINING, ONE HAS A BRUSH THAT IS VERY LOOSE AND EASILY COMES OFF. THE OTHER FIVE PAPETTE BRUSHES ARE SECURELY FASTENED TO THE HANDLES. THE MD WAS ABLE TO REMOVE THE BRUSH FROM THE VAGINAL CANAL AND CONTINUE WITH THE EXAM. THE MD AND STAFF IDENTIFIED THAT THE PATIENT WAS OBESE, BUT BELIEVE THAT THIS WAS NOT A FACTOR IN THIS EVENT.