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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43 2N 48; SUTURE
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TELEFLEX MEDICAL DEK BL MF 0 TC-43 2N 48; SUTURE Back to Search Results
Catalog Number 833-123
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 04/01/2015
Event Type  malfunction  
Event Description
Complaint alleges that the bullet came off the suture while in use with the capio device.The bullet (small fragment tip) was located on an x-ray but they were unable to retrieve it.Patient's condition was reported as unk.
 
Manufacturer Narrative
Qn # (b)(4).A device history record (dhr) review did not show issues related to complaint.No sample is available for the manufacturer to evaluate.However, the manufacturer will continue to monitor and trend relating complaints.
 
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Brand Name
DEK BL MF 0 TC-43 2N 48
Type of Device
SUTURE
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo, tamaulipas 8827 5
MX   88275
Manufacturer Contact
doris sturgis, ra associate
3015 carrington mill blvd
morrisville, NC 27560
9194334953
MDR Report Key4820852
MDR Text Key5840965
Report Number3004365956-2015-00144
Device Sequence Number1
Product Code MFJ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Catalogue Number833-123
Device Lot Number74E1402023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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