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Adverse Event Report

T & S DENTAL & PLASTICS SALIVA EJECTOR   back to search results
Lot Number 98-60046-1
Event Description

Ejector tips dislodged during suction. Further eval revealed that the tips can be dislodged prior to use on pt.

 
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Type of DeviceSALIVA EJECTOR
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
T & S DENTAL & PLASTICS
52 west king st.
myerstown PA 17067
Device Event Key168492
MDR Report Key173296
Event Key162845
Report NumberMW1014030
Device Sequence Number1
Product CodeDYN
Report Source Voluntary
Report Date 06/11/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device LOT Number98-60046-1
OTHER Device ID Number776 1488
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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