KITTNER BLUNT DISSECTORS CD802

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 2010-06-16 for KITTNER BLUNT DISSECTORS CD802 manufactured by Conmed Corporation.

Event Text Entries

[1637202] It was reported, "package is unsealed at the top end times ten (10) packages. " this is a sterile product. Also reported never utilized on patient.
Patient Sequence No: 1, Text Type: D, B5


[8617038] The devices are being returned to conmed however, have not been received to date. Supplemental reports will be filed when quality engineering investigations are complete. Associated medwatch reports: 1320894-2010-00086, 87,88,89,90,91,93,94 and 95.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1320894-2010-00092
MDR Report Key1731125
Report Source06
Date Received2010-06-16
Date of Report2010-06-16
Date Mfgr Received2010-05-14
Device Manufacturer Date2009-10-01
Date Added to Maude2011-01-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSTEPHEN CASANOVA, RN, MPS, SPECIA
Manufacturer Street525 FRENCH RD.
Manufacturer CityUTICA NY 13502
Manufacturer CountryUS
Manufacturer Postal13502
Manufacturer Phone3156243463
Manufacturer G1CONMED CORPORATION
Manufacturer Street525 FRENCH RD.
Manufacturer CityUTICA NY 13502
Manufacturer CountryUS
Manufacturer Postal Code13502
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameKITTNER BLUNT DISSECTORS
Generic NameKITTNER BLUNT DISSECTORS
Product CodeGDI
Date Received2010-06-16
Model NumberNA
Catalog NumberCD802
Lot Number0910081
ID NumberNA
Device Expiration Date2014-10-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONMED CORPORATION
Manufacturer AddressUTICA NY 13502 US 13502


Patients

Patient NumberTreatmentOutcomeDate
10 2010-06-16

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