* 710127-503

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-20 for * 710127-503 manufactured by Welchallyn.

Event Text Entries

[331322] Patient was hospitalized because they were unable to be extubated after dental surgery. The patient had a peripheral iv in their left foot which began to leak. The iv was taken out, and the nurse began to look for another access site. She was unable to find one. So she went to find a transilluminator. The one usually on the unit could not be found, so she went into the pyxias and obtained what she though was another trasilliminator. What the nurse actually picked up was a 3. 5 volt otoscope head. The otoscope on the pyxis was not adequately identified. It was in a tray of unidentified otoscope parts. The nurse knew that a transilliminator was used for but did not appear to recognize that she had not procured the transilluminator from the pyxis. She attached the light to an otoscope handle and used it to find a good access site in the patient's hand. During the access process, the light was held under the patient's hand while an attempt was made to gain iv access. A couple hours later, a blister appeared on the patient's palm. It was not reported to have been a full thickness burn. It was a second degree burn. It was treated with thermazine. There was no further follow up treatment required. In order to prevent future occurrences of this nature, the loose otoscope has been taken off the floor.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number490367
MDR Report Key490367
Date Received2003-10-20
Date of Report2002-11-01
Date of Event2002-11-01
Date Added to Maude2003-10-23
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameOTOSCOPE - HANDLE TOP ASSEMBLY
Product CodeERA
Date Received2003-10-20
Model Number710127-503
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key479102
ManufacturerWELCHALLYN
Manufacturer Address7420 CARROLL ROAD SAN DIEGO CA 92121 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-10-20

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