FDA.reportPublic FDA data

MAUDE MDR 8535852

MDR report key
8535852
Report number
1000317571-2019-00045
Event key
0
Event type
3
Date of event
2019-03-27
Date received
2019-04-22
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
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AQUACEL/AQUACEL AG - EXUDATE MANAGEMENT HYDROFIBER DRESSING ROPEDRESSING,WOUND,HYDROPHILICCONVATEC LTDNAC403770N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-220

Event Narratives#

N

Patient 1

(B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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 THE "AQUACEL RIBBON DISINTEGRATED IN AN ABDOMINAL CAVITY WOUND - DIDN'T COME OUT OF THE CAVITY IN ONE PIECE. THERE WAS A CORRUGATED PLASTIC DRAIN IN THE CAVITY TOO. AROUND 15 CENTIMETERS? LENGTH OF THE AQUACEL RIBBON HAD BEEN PACKED INTO THE WOUND DOWN THE SIDE OF THE CORRUGATED DRAIN AND THE REMAINING 30 CENTIMETERS HAD BEEN LAID OVER THE TOP OF THE WOUND, THE ENTIRE DRESSING HAD DISINTEGRATED INCLUDING THE STITCHING. UNABLE TO REMOVE THE DRESSING EASILY AND THE CORRUGATED DRAIN HAD TO BE REMOVED TO ALLOW NURSE TO IRRIGATE THE WOUND TO REMOVE ALL TRACES OF THE AQUACEL RIBBON." IT WAS FURTHER REPORTED ?AQUACEL? RIBBON DRESSING WAS REMOVED BY WAY OF SALINE IRRIGATION AND THE USE OF A WOUND SWAB TO REMOVE ANY REMNANTS THAT WERE LEFT IN THE BASE OF THE WOUND" AND THERE WAS NO HARM REPORTED.