FDA.reportPublic FDA data

MAUDE MDR 2418301

MDR report key
2418301
Report number
2531468-2011-00004
Event key
0
Event type
3
Date received
2012-01-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
513 S. CLEWELL ST. BETHLEHEM PA 18015 US
Phone
800-800-8004
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HOVERMATT LATERAL PATIENT TRANSFER DEVICEDEVICE, PATIENT TRANSFER, POWEREDD.T. DAVIS ENTERPRISES LTD: T/A HOVERTECH INTERNATIONALFRZHM34HSHM34HSR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-01-1001. O

Event Narratives#

D

Patient 1

IT WAS CONFIRMED THAT PATIENT SUSTAINED AN ORBITAL FRACTURE.

N

Patient 1

D.T. DAVIS ENTERPRISES/HOVERTECH WAS INITIALLY CONTACTED BY A BIOMED TECHNICIAN FOR (B)(4) HOSPITAL ON 12/12/2011. HE NEEDED A COPY OF AN AIR SUPPLY MANUAL TO EVALUATE A HOVERMATT AND AIR SUPPLY THAT WAS INVOLVED IN AN INCIDENT. HE STATED THAT THE PATIENT WAS DROPPED WHILE LEFT UNATTENDED ON AN INFLATED HOVERMATT. THE LABEL ON THE HOVERMATT CLEARLY STATES "NEVER LEAVE PATIENT UNATTENDED ON AN INFLATED HOVERMATT AIR TRANSFER SYSTEM." THE BIOMED DEPARTMENT WAS TESTING THE DEVICES TO ENSURE THAT THEY WORKED PROPERLY. I EMAILED HIM A COPY OF OUR MANUAL AND ASKED WHO I SHOULD CONTACT TO GET MORE INFORMATION ABOUT THE INCIDENT AND PATIENT CONDITION. I CONTACTED THE (B)(6). (B)(6) RETURNED MY CALL ON 12/15/2011 AND SAID SHE WOULD CHECK INTO THE MATTER. SHE CALLED ME BACK TO LET ME KNOW THAT THEIR TESTING VERIFIED THAT THE HOVERMATT AND AIR SUPPLY WERE FUNCTIONING PROPERLY AND WERE NOT THE CAUSE OF THE INCIDENT. THE PATIENT HAD SUSTAINED AN ORBITAL FRACTURE BUT WAS DOING WELL. SHE DID NOT HAVE A SERIAL NUMBER FOR EITHER DEVICE. I E-MAILED HER A COPY OF THE REPORTING FORM TO GET ADDITIONAL INFORMATION. THE FORM WAS NEVER RETURNED. ON 12/19/2011 (B)(6), DEVICE REPORTING ANALYST, LEFT A MESSAGE. SHE STATED THAT BASED ON THE INFORMATION THAT THE FACILITY HAD THEY WOULD NOT MAKE A REPORT TO D.T. DAVIS ENTERPRISES/HOVERTECH, NOR TO THE FDA. THEIR TESTING SHOWED THAT THE HOVERMATT WAS NOT THE ISSUE AND THEY WERE WORKING ON OTHER AVENUES. I CALLED (B)(6) BACK TO DISCUSS THIS REPORT AND LET HER KNOW THAT WE COULD SEND A HOVERTECH REPRESENTATIVE TO RETRAIN THE STAFF ON USING THE HOVERMATT. I HAVE NOT RECEIVED A RETURN PHONE CALL. ALL TESTING WAS PERFORMED BY THE FACILITY. THE DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION.