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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE; K-WIRE
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MICROAIRE SURGICAL INSTRUMENTS MICROAIRE; K-WIRE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Skin Irritation (2076); No Code Available (3191)
Event Type  Injury  
Event Description
Patient had implant and k-wires put in thumb.Patient broke out in blisters on the same hand.Patient was unaware they had a nickel allergy.After having k-wire removed, patient still broke out in blisters.Quick anchor was removed and the blisters started going away.Patient is complaining of eczema and constant itching.
 
Manufacturer Narrative
Due to indications of device being implanted and allergic reaction, occurrence was determined to be reportable to the fda.An fda medwatch report was received by microaire on 03/13/2015 from the fda.(b)(4) was reported by the patient.Since we did not receive any information from the facility that completed the procedure, an initial report was not filed with the fda.
 
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Brand Name
MICROAIRE
Type of Device
K-WIRE
Manufacturer (Section D)
MICROAIRE SURGICAL INSTRUMENTS
3590 grand forks blvd
charlottesville VA
Manufacturer Contact
donna elliott
3590 grand forks blvd
charlottesville, VA 22911
4349758000
MDR Report Key4629598
MDR Text Key5588076
Report Number2020601-2015-00015
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K863734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/13/2015
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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