FDA.reportPublic FDA data

MAUDE MDR 6487627

MDR report key
6487627
Report number
9612030-2017-05055
Event key
0
Event type
3
Date of event
2017-02-27
Date received
2017-04-12
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
1KENDALLBRUSH, SCRUB, OPERATING-ROOMCOVIDIENGEC41589415896285109264XN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-1201. R

Event Narratives#

N

Patient 1

SUBMIT DATE: 04/12/2017 AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

THE CUSTOMER STATES THAT THE SPONGE WAS COMING OFF THE STICK DURING A SURGICAL PROCEDURE. THE DOCTORS HAD TO RETRIEVE THE SPONGE FROM THE PATIENT'S BODY TWICE. ALTHOUGH THERE WAS PATIENT INVOLVEMENT THE CUSTOMER REPORTED THAT NO PATIENT INJURY OCCURRED.

N

Patient 1

THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT. THE COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. THE DEVICE HISTORY RECORD (DHR) FILE WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED MEETING ALL QUALITY STANDARD REQUIREMENTS. THERE WAS NO PHYSICAL SAMPLE RECEIVED FOR THIS REPORT THEREFORE THE ROOT CAUSE OF THE REPORTED CONDITION STATED BY THE CUSTOMER COULD NOT BE DETERMINED. AS NO PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION, THE ROOT CAUSE OF THE REPORTED CONDITION STATED BY THE CUSTOMER COULD NOT BE DETERMINED AND SUBSEQUENTLY NO FORMAL INVESTIGATION ACTIONS ARE BEING TAKEN AT THIS TIME. SHOULD A SAMPLE BE RETURNED IN THE FUTURE, THE COMPLAINT SHALL BE RE-EVALUATED AT THAT TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.