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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE SET
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TELEFLEX MEDICAL RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE SET Back to Search Results
Catalog Number 0055501
Device Problems Failure to Conduct (1114); Optical Problem (3001)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 04/09/2015
Event Type  malfunction  
Event Description
The customer alleges that when the light source is pressed down to activate; the light flickers.No patient injury reported.
 
Manufacturer Narrative
(b)(4).The device sample was not returned for evaluation at the time of this report.
 
Manufacturer Narrative
(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.
 
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Brand Name
RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE SET
Type of Device
LARYNGOSCOPE HANDLE SET
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
2917 weck drive
research triangle park NC 27709
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key4749179
MDR Text Key5771335
Report Number1044475-2015-00158
Device Sequence Number1
Product Code GCI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0055501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/09/2015
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 Unknown
Patient Sequence Number1
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