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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PATTERSON DENTAL SUPPLY INC. PATTERSON SALIVA EJECTORS
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PATTERSON DENTAL SUPPLY INC. PATTERSON SALIVA EJECTORS Back to Search Results
Catalog Number 107-3980
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
A preliminary investigation was performed by the manufacturer on the retained lot.The retained lot conforms to specifications.No root cause has been identified.
 
Event Description
A product complaint ((b)(4)) was reported to amd medicom on (b)(6) 2019 for patterson dental supply inc.Brand product saliva ejector.Item code 107-3980, lot number 20190287v-s4.The saliva ejector is classified as class i medical device under fda code dyn.Saliva electors are used in dentistry in order to remove saliva, blood or other debris from the mouth during dental procedures.This disposable device is connected to an active device, normally a pneumatic system suction circuit.The following information was initially reported: "the tip/head of the saliva ejector came off in patient's mouth.This happened to several patients.Choking hazard".
 
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Brand Name
PATTERSON SALIVA EJECTORS
Type of Device
SALIVA EJECTOR
Manufacturer (Section D)
PATTERSON DENTAL SUPPLY INC.
1031 mendota heights rd.
st. paul MN 65195 3357
Manufacturer Contact
may kansou
MDR Report Key9293334
MDR Text Key202516813
Report Number9611959-2019-00002
Device Sequence Number1
Product Code DYN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number107-3980
Device Lot Number20190287V-S4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age2 MO
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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