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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM INSTRUMENT, LIGATURE PASSING A

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TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM INSTRUMENT, LIGATURE PASSING A Back to Search Results
Catalog Number EFX002
Device Problem Difficult to Remove
Event Date 07/11/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.

 
Event Description

It was reported that prior to observing shield in use during surgery on (b)(6) 2019 the doctor informed me and shared photos of a shield that she used in a case on (b)(6) 2019. No patient injury occurred. The device appears to have had the lower and center portion (the metal that is covered by white plastic of the device bend or twist making it not in alignment with the protective retraction wing. Although no patient injury occurred the doctor did report that it was difficult to retract the wing and remove the device from the patient.

 
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Brand NameWECK EFX SHIELD PORT SITE CLOSURE SYSTEM
Type of DeviceINSTRUMENT, LIGATURE PASSING A
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville , NC 27560
9193614124
MDR Report Key8992931
Report Number3011137372-2019-00306
Device Sequence Number1
Product CodeHCF
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberEFX002
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2019
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

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