FDA.reportPublic FDA data

MAUDE MDR 4501966

MDR report key
4501966
Report number
1018233-2015-00031
Event key
0
Event type
3
Date received
2015-02-06
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
CHRISTY LEWIS
Address
8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALYTE Y MESHBARD SHANNON LIMITEDOTONAY100HUYF0004R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-02-0601. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT FOLLOWING THE MESH PLACEMENT, THE PATIENT DEVELOPED A FEVER. THE PATIENT WAS READMITTED TO THE HOSPITAL 2 DAYS AFTER DISCHARGE AND IS BEING ADMINISTERED ANTIBIOTICS. TO DATE, THE IMPLANT HAS NOT BEEN REMOVED. PER ADDITIONAL FOLLOW UP WITH THE FACILITY ON (B)(6) 2015, THE PATIENT'S FEVER HAD SUBSIDED AND SHE WAS DISCHARGED ON (B)(6) 2015. THE PATIENT'S IMPLANT WILL REMAIN IN PLACE AND THE PATIENT WILL RETURN FOR A FOLLOW UP VISIT TO THE DOCTOR IN A FEW WEEKS.

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.