FDA.reportPublic FDA data

MAUDE MDR 9908978

MDR report key
9908978
Report number
9618003-2020-09218
Event key
0
Event type
3
Date received
2020-03-31
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
MS. JEANETTE JOHNSON
Address
7900 TRIAD CENTER DRIVE SUITE 400 GREENSBORO NC 27409 US
Phone
336-336-3365
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NATURAPROTECTOR, OSTOMYCONVATEC DOMINICAN REPUBLIC INCEXE4131829H04507R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

DEVICE 184 OF 188. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

D

Patient 1

IT WAS REPORTED THAT 188 OUT OF 460 WAFERS FROM THE SAME LOT HAD AN OFF CENTERED STARTER HOLE. THE AFFECTED PRODUCTS WERE NOT USED ON PATIENTS. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.