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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE DERMAFLOAT LAL; PATIENT AIR MATTRESS

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JOERNS HEALTHCARE DERMAFLOAT LAL; PATIENT AIR MATTRESS Back to Search Results
Model Number DFLAL-3680-M
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Head Injury (1879); Laceration(s) (1946)
Event Date 07/18/2020
Event Type  Injury  
Event Description
It was reported to the manufacturer, by the end user, per the end user, that rn walked into bp's room #211a and found him on the floor bleeding from head and had an open would on left arm.Has not been seen by a doctor waiting on supervisor to give approval to go to hospital to have stitches put in his forehead.Bp fell about 5 times out of bed.Complaint #(b)(4) and ra#(b)(4) was entered into our system to have the mattress and control unit returned to joerns for investigation.
 
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Brand Name
DERMAFLOAT LAL
Type of Device
PATIENT AIR MATTRESS
Manufacturer (Section D)
JOERNS HEALTHCARE
avenida pedro hinojosa no. 26
cuidad industrial
matamoras, tamaulipas 87499
MX  87499
Manufacturer (Section G)
JOERNS HEALTHCARE
avenida pedro hinojosa no. 26
cuidad industrial
matamoras, tamaulipas 87499
MX   87499
Manufacturer Contact
mackenzie bay
2100 design rd
arlington, tx 
8260270316
MDR Report Key10409493
MDR Text Key202991635
Report Number3009402404-2020-00029
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberDFLAL-3680-M
Device Catalogue NumberDFLAL-3680-M
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/20/2020
Initial Date FDA Received08/14/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age77 YR
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