FDA.reportPublic FDA data

MAUDE MDR 9415379

MDR report key
9415379
Report number
0002242816-2019-00046
Event key
0
Event type
3
Date received
2019-12-05
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
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, 72RELECTRODESEBI, LLC.LOFN/A106130-20UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-0501. R

Event Narratives#

N

Patient 1

ZIMMER BIOMET COMPLAINT (B)(4). DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2019. MEDICAL PRODUCT: SPINALPAK ASSEMBLY: SERIAL # (B)(4) CATALOG #1067716. THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002242816-2019-00043, 0002242816-2019-00044, 0002242816-2019-00045. DEVICE HAS NOT BEEN RETURNED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION FROM USING THE ELECTRODES AND COVER PATCHES FOR THE SPINALPAK. THE PATIENT SAID THAT THE SKIN WAS RED AND ITCHY WITH LITTLE BUMPS AND SCABS. THE PATIENT SAID THAT THE SKIN IRRITATION WAS PAINFUL. THE PATIENT TRIED TO BREAK UP HER TREATMENT TIME AND USE DIFFERENT ELECTRODES BUT THE SKIN IRRITATION STILL OCCURRED. THE PATIENT CONTACTED HER DOCTOR WHO ADVISED HER TO STOP USING THE SPINALPAK. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.