FDA.reportPublic FDA data

MAUDE MDR 7316587

MDR report key
7316587
Report number
MW5075672
Event key
0
Event type
3
Date of event
2017-12-18
Date received
2018-03-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHARN ANESTHESIA EYEGARDSHEILD, EYE, OPHTHALMICSHARN INC.HOYS-20202180I N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-0501. O

Event Narratives#

D

Patient 1

A PT RECEIVED TOTAL IV ANESTHESIA WITHOUT A PROTECTED AIRWAY. HER EYES WERE PROTECTED WITH THE S-2020 EYEGARDS. WHEN THE DRAPE WAS REMOVED AFTER SURGERY, THE SURGICAL TEAM SAW THE BOTTOM OF THE EYE TAPE HAD COME LOOSE AND THE CHILD'S EYE HAD BEEN OPEN DURING THE PROCEDURE. POSTOPERATIVE, THE PT WAS COMPLAINING OF SEVERE EYE PAIN. OPHTHALMOLOGY WAS CONSULTED. THE PT WAS DIAGNOSED WITH BILATERAL KERATOPATHY AS A RESULT OF INCOMPLETE CLOSURE OF HER EYES DURING THE PROCEDURE. SHE REQUIRED 24 HRS OF ANTIBIOTICS.