FDA.reportPublic FDA data

MAUDE MDR 3415913

MDR report key
3415913
Report number
1316463-2013-00011
Event key
0
Event type
3
Date of event
2013-08-23
Date received
2013-09-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
PEARLEY BHAMBRI, DIR
Address
4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS NY 13153 US
Phone
315-315-3156
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KLEENSPEC 590 SERIES DISP VAGINAL SPECULAWELCH ALLYNHIB5900059000Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-040

Event Narratives#

D

Patient 1

THE CUSTOMER STATED THAT A SMALL SIZED SPECULUM HAD BROKEN DURING A ROUTINE EXAM. THE CUSTOMER STATED THAT THE SPECULUM WAS INSERTED INTO A PT AND THE BOTTOM BILL BROKE; THE PT WAS NOT INJURED. THE CUSTOMER DID NOT PROVIDE A PT IDENTIFIER.

N

Patient 1

WELCH ALLYN IS REPORTING THIS IN AN ABUNDANCE OF CAUTION. THE ACTUAL SPECULUM WAS RETURNED TO WELCH ALLYN. WELCH ALLYN ENGINEERING EVALUATED THE DEVICE AND CONFIRMED A LOWER BILL BREAK. THIS DEVICE IS A MANUALLY INSERTED, DISPOSABLE VAGINAL SPECULUM. THE ROOT CAUSE OF THESE VERY RARE FAILURES WAS DETERMINED TO BE RELATED TO POTENTIAL IMPACTS OR LOADS ON THE SHIPPING CONTAINERS DURING TRANSIT OR STORAGE. METHOD: CUSTOMER CONFIRMED LOWER BILL BREAK. RESULT: VAGINAL SPECULUM. CONCLUSION: ACTUAL DEVICE WAS RETURNED - ENGINEERING CONFIRMED FAILURE MODE BY VISUAL EVAL.