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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: YALE NEEDLES MIS 18GX1 SYRINGE NEEDLE

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YALE NEEDLES MIS 18GX1 SYRINGE NEEDLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Pneumothorax (2012)
Event Date 06/30/2018
Event Type  Injury  
Event Description
Pt had a collapsed lung and shortness of breath. He was hospitalized and was transferred to rehab yesterday.
 
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Brand NameYALE NEEDLES MIS 18GX1
Type of DeviceSYRINGE NEEDLE
MDR Report Key7922595
MDR Text Key122372799
Report NumberMW5080229
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/28/2018 Patient Sequence Number: 1
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