FDA.reportPublic FDA data

MAUDE MDR 8103490

MDR report key
8103490
Report number
2523190-2018-00165
Event key
0
Event type
3
Date of event
2018-08-16
Date received
2018-11-26
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
USER KIMBERLY SHELLY
Address
311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPERATING SCS 6-1/2 STR B/BN/AINTEGRA YORK, PA INC.LRW100138Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-260

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBERS: 2523190-2018-00145; 2523190-2018-00146; 2523190-2018-00147; 2523190-2018-00148; 2523190-2018-00149; 2523190-2018-00150; 2523190-2018-00151; 2523190-2018-00152; 2523190-2018-00153; 2523190-2018-00162; 2523190-2018-00154; 2523190-2018-00155; 2523190-2018-00156; 2523190-2018-00157; 2523190-2018-00163; 2523190-2018-00158; 2523190-2018-00159; 2523190-2018-00160; 2523190-2018-00161; 2523190-2018-00164; 2523190-2018-00166; 2523190-2018-00167.

D

Patient 1

THIS IS 21 OF 23 REPORTS. IT WAS REPORTED BY A CUSTOMER THAT A 100138 OCHSNER OPERATING SCISSOR FAILED QUALITY CONTROL WITH A SUSPECTED BIOBURDEN, CAUSING AN OPERATING ROOM DELAY ON (B)(6) 2018, FOR AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 06-NOV-2018, STATING THAT THE STERILITY OF THE DEVICE WAS COMPROMISED, IT WAS TESTED FOR PROTEINS AND REMOVED FROM THE FIELD. THE SURGICAL CASE WAS BROKEN DOWN. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT. NO REPORTS OF PATIENT INJURY OR DEATH ALLEGED.