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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL UNKNOWN DUMMY MATERIAL
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TELEFLEX MEDICAL SURGICAL UNKNOWN DUMMY MATERIAL Back to Search Results
Catalog Number SURGICAL UNKNOWN
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 02/03/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
 
Event Description
Alleged event: during the firing of the capio device, the tiny titanium bullet on the end of the suture was pulled-off.The bullet was left inside the patient.The patient's condition was reported as unknown.
 
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Brand Name
SURGICAL UNKNOWN DUMMY MATERIAL
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville, NC 27560
9194332672
MDR Report Key5547616
MDR Text Key42437783
Report Number3004365956-2016-00177
Device Sequence Number1
Product Code GEF
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 03/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberSURGICAL UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2016
Initial Date FDA Received04/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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