MAUDE MDR 27443

MDR report key
27443
Report number
MW4000868
Event key
0
Event type
3
Date of event
1995-01-01
Date received
1995-10-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DISPOSABLE BURN SHEETDISPOSABLE BURN SHEETMATRIX MEDICAL, INC.FPYNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-10-060

Event Narratives#

D

Patient 1

RPTR FEELS BURN SHEET IS DEFECTIVE AND REPRESENTS A POTENTIAL DANGER TO PTS. RPTR IS A FULL TIME FACULTY MEMBER OF A MEDICAL SCHOOL DEPT OF EMERGENCY MEDICINE AND MEDICAL DIRECTOR FOR THE PHYSICIAN AND SURGEON AMBULANCE SERVICE. DIRECTOR OF OPERATIONS, BROUGHT TO HIS ATTENTION THAT THE BURN SHEET DISINTEGRATES IN ITS PLASTIC WRAPPER. THE MATERIAL APPEARS TO BE PAPER, AND WHEN REMOVED FROM ITS PLASTIC WRAPPER IS ACCOMPANIED BY A FINE DUST WHICH COULD EASILY BE INHALED (PARTICULARLY IN THE SETTING OF A PT WITH A SUBSTANTIAL BURN) AND IT APPEARS TO BE INNAPROPRIATE COVER FOR ANY BURNED SURFACE. RPTR WAS TOLD THAT THE CITY HEALTH DEPT, WHICH IS RESPONSIBLE FOR INSPECTION OF AMBULANCES, WAS AWARE THIS PRODUCT IS DEFECTIVE AND THEY WOULD NOT CERTIFY AMBULANCES FOR USE BASED UPON THIS PRODUCT'S PRESENCE ON THE UNIT. DIRECTOR OF OPERATIONS ATTEMPTED TO CONTACT THE CO ABOUT THE DEFECT BUT WAS TOLD THAT THE PRODUCT IN THEIR WAREHOUSE WAS NOT DEFECTIVE AND THAT THEY WOULD NOT REMOVE AND REPLACE THIS PRODUCT. RPTR PERSONALLY OBSERVED THE DISSINTEGRATION OF THIS PRODUCT IN TWO SEPARATE NEW CASES. THE DISINTEGRATION OF THIS PRODUCT COULD NOT ONLY DELAY AND COMPLICATE THE APPROPRIATE CARE OF THE PT BUT POTENTIALLY COULD BE INHALED BY A PT WITH A COMPROMISED UPPER AIRWAY.