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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GC CORP. MI PASTE PLUS PROPHY PASTE

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GC CORP. MI PASTE PLUS PROPHY PASTE Back to Search Results
Catalog Number 002888
Device Problem Use of Device Problem (1670)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 08/20/2013
Event Type  Injury  
Manufacturer Narrative
No samples received from dentist. Evaluation based on phone interview. Mi paste and mi paste plus warning statement being reviewed and revised.
 
Event Description
Patient had an alleged reaction to product. Patient's hygienist used mi paste as prophy paste during cleaning appointment for this new patient to their practice. Patient's history had listed numerous allergens. Patient's mother just listed food allergy and was not specific that it was severe allergy to all dairy products. Other known allergies listed were peanuts and (b)(4). As soon as the hygienist started to polish patient's teeth he stopped her after he noticed his mouth was tingling and swelling. He asked her what was in the product and she had to go check. Patient could feel swelling on lips, throat and tongue and immediately started rinsing mouth. Hygienist started to read off what was in the product and came across benzoate allergies and milk protein allergies contraindication and patient then called for his mother to bring in epi pen that was immediately administered in the office by his mother. Patient said he is allergic to all dairy products. Dentist never had a chance to evaluate his patient, the mother immediately took him to the hospital where he was treated in e. R. For an allergic reaction. Patient was administered benadryl 100mg and a prednisone drip to counteract reaction. Patient was first admitted to icu since he is a sleep apnea patient and has lung development issues to watch his oxygen levels. He was released the next morning after reaction subsided and will follow up with his primary physician (b)(6) on (b)(6) 2013.
 
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Brand NameMI PASTE PLUS
Type of DevicePROPHY PASTE
Manufacturer (Section D)
GC CORP.
76-1 hasunuma-cho, itabashi-ku
tokyo 174
JA 174
Manufacturer (Section G)
GC CORP.
76-1 hasumuna-cho, itabashi-ku
tokyo 174
JA 174
Manufacturer Contact
3737 west 127th st.
alsip, IL 60803
7089263090
MDR Report Key3346749
MDR Text Key11289875
Report Number1410097-2013-00003
Device Sequence Number1
Product Code EJR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 09/03/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number002888
Device Lot Number120106V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/03/2013
Distributor Facility Aware Date08/20/2013
Event Location Other
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/06/2013 Patient Sequence Number: 1
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