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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLISON MEDICAL, INC. SURE COMFORT INS SYR 0.5ML 31G 5/16 SYRINGE, PISTON

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ALLISON MEDICAL, INC. SURE COMFORT INS SYR 0.5ML 31G 5/16 SYRINGE, PISTON Back to Search Results
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Event Description
Pt's father (b)(6), states that the syr/needle combo that we have sent with the patient's salzen (the needle) has "broken 3x in the pt's leg" per father's request pls dc all ndls and syr for the pt salzen due rph.
 
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Brand NameSURE COMFORT INS SYR 0.5ML 31G 5/16
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
ALLISON MEDICAL, INC.
MDR Report Key7641110
MDR Text Key112592719
Report NumberMW5078080
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 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
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

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