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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAKANISHI INC. (NSK) NL9000S; DENTAL HANDPIECE, AIR-POWERED, DENTAL

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NAKANISHI INC. (NSK) NL9000S; DENTAL HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 5021262U0
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 03/12/2018
Event Type  Injury  
Event Description
A bur slipped out of the handpiece.The patient swallowed.Medical intervention / hospitalization noted on complaint form.Not able to obtain any patient identification or details after repeated attempts to contact.
 
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Brand Name
NL9000S
Type of Device
DENTAL HANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
NAKANISHI INC. (NSK)
700 shimohinata
kanuma-shi, tochigi-ken, 322-8 6666
JA  322-86666
MDR Report Key7441515
MDR Text Key105874281
Report Number1032227-2018-00002
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Catalogue Number5021262U0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2018
Distributor Facility Aware Date03/22/2018
Device Age10 MO
Event Location Other
Date Report to Manufacturer04/18/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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