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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PURITAN MEDICAL PRODUCTS COMPANY LLC FOR NATUS MEDICAL ORASWAB; ABSORBENT TIPPED APPLICATOR
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PURITAN MEDICAL PRODUCTS COMPANY LLC FOR NATUS MEDICAL ORASWAB; ABSORBENT TIPPED APPLICATOR Back to Search Results
Model Number 006481
Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Our investigation of the batch records and returned samples did not reveal any abnormalities.Our investigation could not detect a device defect associated with this incident.Info from this incident will be included in our product complaint trending system.
 
Event Description
Foam tip detached in pt's mouth.Foam tip retrieved by nurse.
 
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Brand Name
ORASWAB
Type of Device
ABSORBENT TIPPED APPLICATOR
Manufacturer (Section D)
PURITAN MEDICAL PRODUCTS COMPANY LLC FOR NATUS MEDICAL
Manufacturer Contact
william young
31 school st.
p.o. box 149
guilford, ME 04443
2078763311
MDR Report Key5022484
MDR Text Key24600813
Report Number1216735-2015-00002
Device Sequence Number1
Product Code KXF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Report Date 08/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number006481
Device Catalogue Number006481
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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