PILLING COOLEY STERNAL RETRACTOR ADULT 341194

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-04 for PILLING COOLEY STERNAL RETRACTOR ADULT 341194 manufactured by Teleflex.

Event Text Entries

[16011419] The event is reported as: alleged issue: during use on the pt in operating room, the retractor got loose gradually without being noticed and the opened abdomen part of the pt was suddenly closed. No reported injury.
Patient Sequence No: 1, Text Type: D, B5


[16510032] The device sample was not received by the mfr at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2013-00142
MDR Report Key3371285
Report Source05,06
Date Received2013-09-04
Date of Report2013-08-16
Date of Event2013-08-14
Date Mfgr Received2013-08-16
Date Added to Maude2013-12-04
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 CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334957
Manufacturer G1TELEFLEX
Manufacturer Street2917 WECK DR.
Manufacturer CityRTP NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePILLING COOLEY STERNAL RETRACTOR ADULT
Generic NameSTERNAL RETRACTOR
Product CodeEIG
Date Received2013-09-04
Catalog Number341194
Lot NumberQQ9
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressRESEARCH TRIANGLE PARK NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2013-09-04

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