SPONGE HOLDING FORCEPS 32-6010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for SPONGE HOLDING FORCEPS 32-6010 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[93050344]
Patient Sequence No: 1, Text Type: N, H10


[93050345] Tip of forceps broke off during use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7062774
MDR Report Key7062774
Date Received2017-11-28
Date of Report2017-11-22
Date of Event2017-11-06
Report Date2017-11-20
Date Reported to FDA2017-11-20
Date Reported to Mfgr2017-11-20
Date Added to Maude2017-11-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPONGE HOLDING FORCEPS
Generic NameINSTRUMENT, SURGICAL, FORCEPS
Product CodeHCZ
Date Received2017-11-28
Model Number32-6010
Catalog Number32-6010
OperatorPHYSICIAN
Device AvailabilityY
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 2017-11-28

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