FDA.reportPublic FDA data

MAUDE MDR 3409629

MDR report key
3409629
Report number
2523835-2013-00122
Event key
0
Event type
3
Date of event
2013-04-19
Date received
2013-09-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CYNTHIA KAY
Address
6201 S. FREEWAY R3-48 FORT WORTH TX 76134 US
Phone
817-817-8176
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POLYMER I/A TIP, DISPOSABLENEEDLE, ASPIRATION AND INJECTION, DISPOSABLEALCON PRECISION DEVICE - SINKING SPRINGHQRNA8065751511UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-240

Event Narratives#

D

Patient 1

A CUSTOMER REPORTED BURNS ON THE TIPS OF THE IRRIGATION/ASPIRATION (I/A) HANDPIECE. THE TIP WAS EXCHANGED AND THE SURGERY WAS COMPLETED WITH NO IMPACT TO THE PT. ADDITIONAL INFO WAS RECEIVED FROM THE CUSTOMER REPORTED THAT THE BURRS ON THE TIPS WERE OBSERVED UNDER THE MICROSCOPE DURING SURGERY.

N

Patient 1

NO SAMPLES WERE RETURNED FOR EVAL FOR "BURR ON TIP". NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. THE ROOT CAUSE FOR "BURR ON TIP" CANNOT BE DETERMINED FROM THIS EVAL. ALL SINGLE USE I/A TIPS ARE 100% VISUALLY INSPECTED PRIOR TO THEIR RELEASE. (B)(4).