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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL DURAHOOK 1/4 HOOK
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TELEFLEX MEDICAL DURAHOOK 1/4 HOOK Back to Search Results
Catalog Number 382800
Device Problem Degraded (1153)
Patient Problem Not Applicable (3189)
Event Date 07/17/2015
Event Type  malfunction  
Event Description
Alleged event: the durahooks are dry rotting which is evident through the packaging.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).The device history review for the product durahook 1/4 hook 10 pkg/bx 6 hks/pkg, lot number 73m1400048 did not show issues related to the complaint.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.
 
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Brand Name
DURAHOOK 1/4 HOOK
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 2147 8
MX   21478
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville, NC 27560
9194332672
MDR Report Key4952369
MDR Text Key6192591
Report Number3003898360-2015-00544
Device Sequence Number1
Product Code GDG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/12/2016
Device Catalogue Number382800
Device Lot Number73M1400048
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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