FDA.reportPublic FDA data

MAUDE MDR 8637304

MDR report key
8637304
Report number
1049092-2019-00199
Event key
0
Event type
3
Date received
2019-05-23
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
211 AMERICAN AVENUE GREENSBORO NC 27409 US
Phone
336-336-3365
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AQUACEL FOAMDRESSING,WOUND,HYDROPHILICCONVATEC INCNAC4206362673620R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-230

Event Narratives#

N

Patient 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

D

Patient 1

IT WAS REPORTED THE "AQUACEL INSIDE OF FOAM CANNOT ABSORB EXUDATE PROPERLY". THE DRESSING WAS REPORTED TO BE CHANGED EVERY THIRD DAY WHICH END USER ALLEGES LED PRIMARILY TO MACERATION AS WELL AS NECROSIS THAT OCCURRED ON A SMALL WOUND AREA. THE TREATING PHYSICIAN NOTICED A CHANGE IN THE WOUND BUT, WAS UNABLE TO CONFIRM WHEN THE CHANGE OCCURRED. THE PATIENT DID NOT HAVE ANY SERIOUS PROBLEMS THAT REQUIRED MEDICAL TREATMENT OTHER THAN DEBRIDEMENT OF THE AFFECTED AREA. PER THE INFORMATION PROVIDED, THE END USER HAS MULTIPLE WOUNDS WITH MULTIPLE DRESSINGS USED FROM MULTIPLE LOTS. THE TOTAL AMOUNT OF DRESSINGS RELATED TO THE MACERATION AND NECROSIS IS STILL UNKNOWN. PHOTOGRAPHS OF THE PRODUCT WERE PROVIDED.