SURGICAL PATTIE, 1/2 X 1/2 80-1400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-05-23 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[109017370] (b)(4). It has been reported that the device would not be returned for evaluation. A lot number was provided. Upon review of the manufacturing records, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[109017591] As reported by the ous affiliate, a codman pattie did not have a string attached. The pattie never entered the patient's body, but was contaminated with blood and discarded. There were no reports of delay or patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226348-2018-10363
MDR Report Key7536544
Report SourceFOREIGN,USER FACILITY
Date Received2018-05-23
Date of Report2018-05-01
Date of Event2018-05-01
Date Mfgr Received2018-05-29
Device Manufacturer Date2017-09-26
Date Added to Maude2018-05-23
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 FDA3
Event Location3
Manufacturer ContactMS JAMES KENNEY
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone5088282726
Manufacturer G1CODMAN & SHURTLEFF, INC.
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGICAL PATTIE, 1/2 X 1/2
Generic NameSURGICAL SPONGE
Product CodeHBN
Date Received2018-05-23
Catalog Number80-1400
Lot NumberHF5548
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCODMAN & SHURTLEFF, INC.
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-23

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