FDA.reportPublic FDA data

MAUDE MDR 6121114

MDR report key
6121114
Report number
9612030-2016-00674
Event key
0
Event type
3
Date received
2016-11-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
EDWARD ALMEIDA
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13612 LITE GLOVELITE GLOVECOVIDIENLYU3114025731140257* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-220

Event Narratives#

N

Patient 1

SUBMIT DATE: 11/22/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

D

Patient 1

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT THE LITE GLOVE TORE WHEN THE SURGEON GRABBED THE LITE HANDLE DURING A PROCEDURE. THE PATIENT WAS PRESENT AND OPENED. THE SURGEON CHANGED THEIR GLOVES, THE LITE HANDLE AND THE LITE GLOVE. THERE WAS NO ADDITIONAL MEDICATION GIVEN TO THE PATIENT.