UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-01-31 for UNKNOWN manufactured by Unk.

Event Text Entries

[2470290] During surgical repair of multiple full-thickness eyelid lacerations and superior canalicular laceration of the right eye (caused by a dog bite), the tip of the nasolacrimal probe retrieval hook broke and became embedded in the right inferior turbinate. The lacerations were repaired and the child was discharged with follow-up instructions and appointments.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2435879
MDR Report Key2435879
Report Source99
Date Received2012-01-31
Date of Report2011-04-28
Date of Event2011-03-05
Date Facility Aware2011-03-05
Report Date2011-04-28
Date Added to Maude2012-02-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameCRAWFORD RETRIEVING HOOK
Product CodeHNL
Date Received2012-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-01-31

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