FDA Adverse Event Injury Summary report: N

LOUPE

MDR report key: 8928204 · Received August 23, 2019

Report

Report Number: 3003848022-2019-00001
Event Type: Injury
Date Received: August 23, 2019
Report Date: August 23, 2019
Manufacturer: METREX RESEARCH LLC DBA ORASCOPTIC, SURGICAL ACUIT
Product Code: EBA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SPECIFIC INFORMATION SUCH AS AGE, WEIGHT, ETHNICITY WAS NOT PROVIDED. DATE OF EVENT WAS NOT PROVIDED. THE CUSTOMER REPORTEDLY TRIPPED AND FELL INCURRING INJURIES. THE LOUPE FRAME CONTRIBUTED TO THE INJURIES AS SHE REPORTED THAT THE FRAME CONTACTED HER ABOVE HER LEFT EYE, CUTTING HER DURING THE FALL. THE CUT ABOVE HER LEFT EYE, CUTTING HER DURING THE FALL. THE CUT ABOVE HER LEFT EYE REQUIRED MEDICAL ATTENTION, STITCHES. THE LOUPES DID NOT FAIL DUE TO A MANUFACTURER DEFECT. THE LOUPES FAILED DUE TO THE CUSTOMER ADMITTEDLY TRIPPING AND FALLING ON THEM. THE CUSTOMER DID SUSTAIN SOME INJURIES; HOWEVER THIS WAS NOT DUE TO A MALFUNCTION OF THE LOUPES. UPON RECEIPT FOR REPAIR, THE LOUPES AND THE OCULAR WERE STILL FULLY BONDED TO THE CARRIERS AND THE FRAME WAS NOT DAMAGED. THE LEFT OCULAR HOWEVER HAD BOTH THE BUTTON AND OBJECTIVE LENSES OUT AND IS BROKEN BEYOND REPAIR.

Description of Event or Problem · 1

AN ALLEGED COMPLAINT WAS REPORTED THAT A CUSTOMER REPORTED THAT SHE TRIPPED AND FELL ON HER FACE WHILE WEARING HER LOUPES. THE CUSTOMER REPORTED THAT THE FRAME OF THE LOUPE CUT HER ABOVE HER LEFT EYE AND THAT SHE ALSO BROKE HER NOSE DURING THE FALL. THE CUSTOMER REPORTED DAMAGE TO THE LOUPES INVOLVED THE LEFT OCULAR BEING BROKEN OUT, WITH TWO INTERNAL PIECES COMING OUT OF THE OCULAR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
722219	LOUPE	SURGICAL HEADLIGHT	EBA	METREX RESEARCH LLC DBA ORASCOPTIC, SURGICAL ACUIT		096435

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other