MORSE STERNAL RETRACTOR ADULT 8" 341162

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 2013-10-21 for MORSE STERNAL RETRACTOR ADULT 8" 341162 manufactured by Teleflex.

Event Text Entries

[3978817] Customer called to report that the hook on the device broke after the procedure was completed. There was no patient injury. Patient current condition is fine.
Patient Sequence No: 1, Text Type: D, B5


[11453010] The device sample was not received by the manufacturer in time for this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2013-00195
MDR Report Key3537224
Report Source06
Date Received2013-10-21
Date of Report2013-10-07
Date of Event2013-10-07
Date Mfgr Received2013-10-07
Date Added to Maude2014-01-23
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 FDA0
Event Location0
Manufacturer ContactELAINE BURKLE, RN
Manufacturer StreetPO BOX 12600
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334957
Manufacturer G1TELEFLEX
Manufacturer Street2917 WECK DR.
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMORSE STERNAL RETRACTOR ADULT 8"
Generic NameSTERNAL RETRACTOR
Product CodeEIG
Date Received2013-10-21
Catalog Number341162
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressRESEARCH TRIANGLE PARK NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2013-10-21

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