FDA.reportPublic FDA data

MAUDE MDR 8176354

MDR report key
8176354
Report number
1018120-2018-00322
Event key
0
Event type
3
Date of event
2018-11-16
Date received
2018-12-18
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
12733 SPG GAUZE 4X4-16PLYFIBER, MEDICAL, ABSORBENTCOVIDIENFRL2733273318D149762R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-180

Event Narratives#

N

Patient 1

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

D

Patient 1

THE CUSTOMER STATES THE GAUZE IS COMING APART; EXCESSIVE LINTING.