FDA.reportPublic FDA data

MAUDE MDR 9841673

MDR report key
9841673
Report number
0002242816-2020-00029
Event key
0
Event type
3
Date received
2020-03-17
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
1ELECTRODES, LT-4500ELECTRODESEBI, LLC.LOFN/A106130-12913014R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1701. R

Event Narratives#

N

Patient 1

DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2020. CONCOMITANT MEDICAL PRODUCT: ORTHOPAK ASSEMBLY: CATALOG: #1067718, SERIAL: # (B)(4). THERAPY DATE: UNKNOWN. CONCOMITANT MEDICAL PRODUCT: SMITH & NEPHEW TAYLOR SPATIAL FRAME. THERAPY DATE: (B)(6) 2019. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002242816-2020-00028.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION FROM THE 72R AND LT-4500 ELECTRODES. THE PATIENT DESCRIBED THE SKIN AS RED AND ITCHY WITH BLISTERS AND WELTS. INITIALLY, THE IRRITATION WAS STRICTLY UNDER THE ELECTRODES BUT THE IRRITATION BEGAN TO SPREAD. THE PATIENT DID CONTACT THE SURGEON REGARDING THE SKIN IRRITATION. THE SURGEON ADVISED THE PATIENT TO STOP USING THE UNIT AND PRESCRIBED AN OINTMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.