DEK BL MF 0 TC-43/HR 26 2N 36" 833-124

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-11 for DEK BL MF 0 TC-43/HR 26 2N 36" 833-124 manufactured by Teleflex Medical.

Event Text Entries

[31200074] (b)(4). The device history record of batch number 74e1402012 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. The device sample was reportedly discarded. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[31200075] Alleged event: two metal darts at the end of the sutures broke off inside the patient and they were not retrieved. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2015-00341
MDR Report Key5217223
Date Received2015-11-11
Date of Report2015-11-06
Date of Event2015-10-30
Date Mfgr Received2015-11-06
Device Manufacturer Date2014-05-20
Date Added to Maude2015-11-11
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 FDA3
Event Location3
Manufacturer ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDEK BL MF 0 TC-43/HR 26 2N 36"
Product CodeOVN
Date Received2015-11-11
Catalog Number833-124
Lot Number74E1402012
Device Expiration Date2019-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-11

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