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 from a company representative,health report with the FDA on 2015-08-31 for DEK BL MF 0 TC-43/HR 26 2N 36" 833-124 manufactured by Teleflex Medical.

Event Text Entries

[24617693] (b)(4). The device history record of batch numbers (74d1501897, 74f1400285 & 74l1402847) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. The device sample has not been returned for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[24617694] Alleged event: after a bullet detached and fell inside the patient, they loaded a second polypro suture outside the patient and the bullet fell off. A different polypro suture was used to complete the case. The patient's condition was reported as stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2015-00268
MDR Report Key5042587
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2015-08-31
Date of Report2015-08-11
Date of Event2015-08-07
Date Mfgr Received2015-08-11
Date Added to Maude2015-08-31
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 Report3

Device Details

Brand NameDEK BL MF 0 TC-43/HR 26 2N 36"
Generic NameSUTURE
Product CodeOVN
Date Received2015-08-31
Catalog Number833-124
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-31

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