FDA.reportPublic FDA data

MAUDE MDR 7807731

MDR report key
7807731
Report number
2182318-2018-00006
Event key
0
Event type
3
Date received
2018-08-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JACKIE KRIEGLSTEIN
Address
570 ENTERPRISE DRIVE NEENAH WI 54956 US
Phone
920-920-9207
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1C-ARMORC-ARMOR DRAPEPUI5523019269Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-220

Event Narratives#

N

Patient 1

AFFECTED PRODUCT WAS RETURNED AND MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED FOREIGN MATERIAL IN THE PRODUCT. INSPECTION OF THE MATERIAL DETERMINE IT IS NON-BIOLOGICAL IN ORIGIN. AT THIS TIME, THE INVESTIGATION IS ONGOING AND NO FURTHER INFORMATION IS AVAILABLE. (B)(4).

D

Patient 1

CUSTOMER DETECTED FOREIGN CONTAMINANT IN STERILE DRAPE WHILE PREPPING THE PATIENT. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.