BOOKWALTER RET ML BL 3X6 50-4567

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-12-02 for BOOKWALTER RET ML BL 3X6 50-4567 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[1745278] Affiliate reported that the blade broke off the handle during use in a gastric operation. It was reported that the blades were recovered, however, as a result, surgery was delayed.
Patient Sequence No: 1, Text Type: D, B5


[8868555] Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226348-2010-00395
MDR Report Key1937806
Report Source01,07
Date Received2010-12-02
Date of Event2010-09-16
Date Mfgr Received2010-11-10
Date Added to Maude2011-01-24
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 ContactMATTHEW KING
Manufacturer Street325 PARAMOUNT DR.
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone5088283106
Manufacturer G1CODMAN & SHURTLEFF, INC.
Manufacturer Street325 PARAMOUNT DR.
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameBOOKWALTER RET ML BL 3X6
Generic NameRETRACTORS
Product CodeDWH
Date Received2010-12-02
Model NumberNA
Catalog Number50-4567
Lot Number093
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCODMAN & SHURTLEFF, INC.
Manufacturer Address325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2010-12-02

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