HS DSP EAR CUR LG SPOON 9004672

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2013-10-29 for HS DSP EAR CUR LG SPOON 9004672 manufactured by Integra York, Pa Inc..

Event Text Entries

[3849331] Customer initially reports pts were scratched in the ear canal. Drew a little blood but no hospitalization was needed. On (b)(6) 2013, doctor reports she was using device to remove ear wax for which it was intended, causing cuts in the ear canal mucosa at a lightest touch, when it is introduced to the ear canal. It caused ear canal bleeding in the 3 pts i use it on right away, before i was even able to get any of the wax out. No harm beyond the scratch, treated with antibiotic drops x bid for 3 days. On (b)(6) 2013... This is pt #2 of 3 pts. (slee).
Patient Sequence No: 1, Text Type: D, B5


[11240018] To date, the device involved in the reported incident has not been rec'd for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523190-2013-00064
MDR Report Key3445393
Report Source06,08
Date Received2013-10-29
Date of Report2013-10-29
Date Mfgr Received2013-10-02
Date Added to Maude2013-11-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSANDRA LEE
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer Phone6099366828
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHS DSP EAR CUR LG SPOON
Generic NameM11 - ENT
Product CodeJZE
Date Received2013-10-29
Catalog Number9004672
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer AddressYORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2013-10-29

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