DEK BL MF 0 TC-43/HR 36 2N 833-124

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2014-01-09 for DEK BL MF 0 TC-43/HR 36 2N 833-124 manufactured by Teleflex Medical.

Event Text Entries

[4248769] The event is reported as: complaint alleges: surgeon reported the capio bullet needle had gotten dislodged from the suture and got stuck in the sacrospinous ligament, and the surgeon decided to leave it, because it would have been too dangerous to retrieve. No pt complications. No reported pt injury.
Patient Sequence No: 1, Text Type: D, B5


[11606446] A device history record (dhr) review could not be conducted since the lot number was not provided. No corrective actions can be implemented due to the lack of product sample and batch number to perform a proper investigation and determine the root cause. Customer complaint cannot be confirmed due to the lack of product sample and batch number to perform a proper investigation and determine the root cause.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2014-00009
MDR Report Key3702917
Report Source01,05,06,08
Date Received2014-01-09
Date of Report2013-12-16
Date of Event2011-01-01
Date Mfgr Received2013-12-16
Date Added to Maude2014-04-22
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 ContactJASMINE BROWN
Manufacturer StreetPO BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9193614124
Manufacturer G1TELEFLEX
Manufacturer StreetAVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEK BL MF 0 TC-43/HR 36 2N
Generic NameSUTURE
Product CodeGAO
Date Received2014-01-09
Catalog Number833-124
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressNUEVO LAREDO MX


Patients

Patient NumberTreatmentOutcomeDate
10 2014-01-09

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