FDA.reportPublic FDA data

MAUDE MDR 6778447

MDR report key
6778447
Report number
1018120-2017-05070
Event key
0
Event type
3
Date received
2017-08-09
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
1CURITYGAUZE/SPONGE, INTERNALCOVIDIENEFQ78317831* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-0901. O

Event Narratives#

N

Patient 1

SUBMIT DATE: 8/9/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY; 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 (PATIENT) STATES THAT SHE GOT A STAPH INFECTION FROM C-SECTION IN 2012. THE CUSTOMER STATES THAT THE USE OF 'KENDALL CURITY IODOFORM PACKING MATERIAL STRIP' WAS USED OUT OF DATE. THE PRODUCT EXPIRED ON JANUARY 2008 AND SECOND BOTTLE OF SAME PRODUCT USED ON THE PATIENT EXPIRED ON JUNE 2009.

N

Patient 1

SUBMIT DATE: 5/25/2018. THERE WERE NO SAMPLES RECEIVED WITH THIS COMPLAINT THEREFORE AN EXAMINATION OF THE REPORTED ISSUE COULD NOT BE MADE. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED DURING THIS INVESTIGATION AS THE LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY PRIOR TO RELEASE OF PRODUCT. BECAUSE THERE WAS NO LOT NUMBER, A DATE OF MANUFACTURE COULD NOT BE DETERMINED. SINCE THIS COMPLAINT WILL BE CONSIDERED UNCONFIRMED, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION OR SAMPLES ARE RECEIVED, THE INVESTIGATION WILL RESUME AS NEEDED. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.