FDA.reportPublic FDA data

MAUDE MDR 9475504

MDR report key
9475504
Report number
0002242816-2019-00051
Event key
0
Event type
3
Date received
2019-12-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SARA DAILEY
Address
399 JEFFERSON ROAD PARSIPPANY NJ 07054 US
Phone
973-973-9732
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOFT-TOUCH ELECTRODES, 63BELECTRODESEBI, LLC.LOFN/A106130-22UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-1601. R

Event Narratives#

N

Patient 1

ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCT: SPINALPAK ASSEMBLY: CATALOG #1067716, SERIAL #(B)(4). THERAPY DATE: UNKNOWN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SKIN IRRITATION FROM THE 63B ELECTRODES. THE PATIENT HAS BEEN USING THE 63B ELECTRODES FOR SEVERAL MONTHS AND SAID THAT THE NEW BATCH WAS CAUSING SKIN IRRITATION. THE PATIENT HAS BEEN USING HYDROCORTISONE CREAM ON THE SKIN IRRITATION. THE PATIENT CONTACTED THE DOCTOR'S OFFICE AND WAS ADVISED TO STOP WEARING THE UNIT UNTIL THE SKIN IS COMPLETELY HEALED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.