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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECIALTY APPLIANCE WORKS, INC HERBST APPLIANCE; HERBST SCREW
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SPECIALTY APPLIANCE WORKS, INC HERBST APPLIANCE; HERBST SCREW Back to Search Results
Catalog Number 10040T
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/12/2017
Event Type  malfunction  
Manufacturer Narrative
A doctor's office alleged that a patient swallowed a herbst appliance screw.Upon initial report, the mother confirmed that the patient passed the screw.The patient did not require any medical intervention to remove the screw.No complications or adverse symptoms have been noted.The doctor requested a replacement screw.The patient is continuing treatment with the original appliance and the replacement screw.The appliance was not returned so an evaluation could not be performed.The report was filed as a malfunction as a precaution due to lack of information.
 
Event Description
A doctor's office alleged that a patient swallowed a herbst appliance screw.Upon initial report, the mother confirmed that the patient passed the screw.The patient did not require any medical intervention to remove the screw.No complications or adverse symptoms have been noted.The doctor requested a replacement screw.The patient is continuing treatment with the original appliance and the replacement screw.The appliance was not returned so an evaluation could not be performed.
 
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Brand Name
HERBST APPLIANCE
Type of Device
HERBST SCREW
Manufacturer (Section D)
SPECIALTY APPLIANCE WORKS, INC
49005 hammond industrial drive
cumming GA 30041
Manufacturer (Section G)
SPECIALTY APPLIANCE WORKS, INC
4905 hammond industrial drive
cumming GA 30041
Manufacturer Contact
carolyn thomas
4905 hammond industrial drive
cumming, GA 30041
6785134408
MDR Report Key6768155
MDR Text Key82043282
Report Number3004158247-2017-00001
Device Sequence Number1
Product Code ECN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number10040T
Device Lot Number6640075
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Device Age1 MO
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age13 YR
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