ROTOPRONE 209800

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 2020-02-10 for ROTOPRONE 209800 manufactured by Arjohuntleigh, Inc..

Event Text Entries

[188581340] Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4). Currently, this product is to be handled by (b)(4) ab? S complaint handling establishment and any medwatch reports will be submitted under registration (b)(4). Additional information will be provided once the investigation conclusions are available.
Patient Sequence No: 1, Text Type: N, H10


[188581341] Patient had developed bilateral deep tissue on forehead and cheeks. Injuries developed within 12-18 hours while the patient was in prone position. There was no product failure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681684-2020-00011
MDR Report Key9687047
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-10
Date of Report2020-03-11
Date of Event2019-12-19
Date Mfgr Received2020-01-13
Date Added to Maude2020-02-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKINGA STOLINSKA
Manufacturer StreetKS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI 62-052
Manufacturer CountryPL
Manufacturer Postal62-052
Manufacturer Phone688282467
Manufacturer G1ARJOHUNTLEIGH MAGOG INC.
Manufacturer Street2001 TANGUAY STREET
Manufacturer CityMAGOG J1X5Y5
Manufacturer CountryCA
Manufacturer Postal CodeJ1X5Y5
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROTOPRONE
Generic NameBED, PATIENT ROTATION, POWERED
Product CodeIKZ
Date Received2020-02-10
Model Number209800
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. Other 2020-02-10

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