FDA.reportPublic FDA data

MAUDE MDR 6178528

MDR report key
6178528
Report number
1416605-2016-00008
Event key
0
Event type
3
Date received
2016-12-15
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
MRS. MARIA VRABIE
Address
3232 N ROCKWELL ST CHICAGO IL 60618 US
Phone
773-773-7738
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HU-FRIEDY MFG. CO., LLCLIGATURE WIREHU-FRIEDY MFG. CO., LLCDYXWPLW25WPLW25N *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-1501. O

Event Narratives#

N

Patient 1

HU-FRIEDY DOES NOT TRACK OUR DEVICES (WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES) BY SERIAL NUMBER OR UDI, ONLY BY A LOT NUMBER, WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. REPROCESSOR DOES NOT APPLY NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES PROVIDED. PMA/510(K) IS NOT APPLICABLE. IND IS NOT APPLICABLE.

D

Patient 1

A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER HER CHEEKBONE WAS STABILIZED WITH 25 GAUGE STAINLESS STEEL WIRE.