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 company representative,health report with the FDA on 2018-12-21 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[131507104] (b)(4). The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[131507125] As reported by the sales rep, the surgical patties did not show up on the xray while in the patient. There were no reports of delay or patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226348-2018-10904
MDR Report Key8189838
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-12-21
Date of Report2018-12-04
Date of Event2018-12-03
Date Mfgr Received2019-02-05
Device Manufacturer Date2018-07-24
Date Added to Maude2018-12-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKAREN ANIGBO
Manufacturer Street11 CABOT BOULEVARD
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone7819715608
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 Received2018-12-21
Returned To Mfg2018-12-07
Catalog Number80-1400
Lot NumberHZ1244
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCODMAN & SHURTLEFF, INC.
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-21

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