KLEENSPEC 590 SERIES DISP VAGINAL SPECULA 59001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-04 for KLEENSPEC 590 SERIES DISP VAGINAL SPECULA 59001 manufactured by Welch Allyn.

Event Text Entries

[19585451] The customer stated that a medium sized speculum had broken during a routine exam. The customer states that the speculum was inserted into a pt and the bottom bill broke into two pieces; the pt was not injured. The customer did not provide a pt identified.
Patient Sequence No: 1, Text Type: D, B5


[19829717] Welch allyn is reporting this in an abundance of caution. The actual speculum was not returned to welch allyn. 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. No further investigation will be performed. Method: customer confirmed lower bill break. Result: vaginal speculum. Conclusion: actual device not returned.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1316463-2013-00010
MDR Report Key3415907
Report Source06
Date Received2013-09-04
Date of Report2013-08-07
Date of Event2013-08-07
Date Mfgr Received2013-08-07
Date Added to Maude2013-12-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactPEARLEY BHAMBRI, DIR
Manufacturer Street4341 STATE ST. RD. P.O. BOX 220
Manufacturer CitySKANEATELES FALLS NY 131530220
Manufacturer CountryUS
Manufacturer Postal131530220
Manufacturer Phone3156852568
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKLEENSPEC 590 SERIES DISP VAGINAL SPECULA
Product CodeHIB
Date Received2013-09-04
Model Number59001
Catalog Number59001
Lot Number195352
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWELCH ALLYN
Manufacturer Address4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153


Patients

Patient NumberTreatmentOutcomeDate
10 2013-09-04

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