ROTOPRONE 209800-R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-09 for ROTOPRONE 209800-R manufactured by Arjohuntleigh, Inc..

Event Text Entries

[132489310] (b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[132489311] Arjo was notified about patient sustaining deep tissue injuries to both cheeks while using rotoprone bed. The bilateral injuries were first noticed on (b)(6) 2018 and described as maroon in color at the time, but progressed to some blistering and open skin. A wound care nurse also noted very edematous face and tight ett tape around cheeks. Patient has been treated daily with mepilex dressing to face to help with wounds.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681684-2019-00003
MDR Report Key8230461
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-01-09
Date of Report2019-02-07
Date of Event2018-12-12
Date Mfgr Received2018-12-12
Date Added to Maude2019-01-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KINGA STOLINSKA
Manufacturer StreetUL. KS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI, 62-052, P
Manufacturer CountryPL
Manufacturer Postal62-052, PL
Manufacturer G1ARJOHUNTLEIGH, INC.
Manufacturer Street4958 STOUT DRIVE
Manufacturer CitySAN ANTONIO TX 78219
Manufacturer CountryUS
Manufacturer Postal Code78219
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROTOPRONE
Generic NameBED, PATIENT ROTATION, POWERED
Product CodeIKZ
Date Received2019-01-09
Model Number209800-R
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARJOHUNTLEIGH, INC.
Manufacturer Address4958 STOUT DRIVE SAN ANTONIO TX 78219 US 78219


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-01-09

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