ADSN TISS FCPS 4-3/4 1X2 6-120

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 2014-06-26 for ADSN TISS FCPS 4-3/4 1X2 6-120 manufactured by Integra York, Pa Inc..

Event Text Entries

[18070526] Customer initially reports teeth broke while treating pt. On (b)(6) 2014, customer reports tip from the one tooth side of forcep broke off in pt lip when a biopsy was being taken. Tip was removed easily. No harm to pt. Event date not available, (b)(6).
Patient Sequence No: 1, Text Type: D, B5


[18428143] To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523190-2014-00047
MDR Report Key3958804
Report Source06
Date Received2014-06-26
Date of Report2014-06-12
Date of Event2014-06-02
Date Mfgr Received2014-06-13
Date Added to Maude2014-08-01
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 ContactSANDRA LEE
Manufacturer Street315 ENTERPRISE DR
Manufacturer Phone6019366828
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADSN TISS FCPS 4-3/4 1X2
Generic NameM5-GENERAL SURGERY
Product CodeEKD
Date Received2014-06-26
Catalog Number6-120
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer AddressYORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2014-06-26

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