FDA.reportPublic FDA data

MAUDE MDR 9836517

MDR report key
9836517
Report number
9618003-2020-07762
Event key
0
Event type
3
Date received
2020-03-16
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
1DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSINGDRESSING,WOUND,OCCLUSIVECONVATEC DOMINICAN REPUBLIC INCNAD1879559J01693N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-160

Event Narratives#

N

Patient 1

DEVICE 4 OF 9. (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 ?THERE WAS A BLACK SPOT FOUND IN THE PACKAGE.? THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.