ISOFLEX LAL 2860 2860000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for ISOFLEX LAL 2860 2860000000 manufactured by Stryker Medical London Dba Chg Hospital Beds.

Event Text Entries

[114138830] It was alleged that the customer was experiencing a general increase in pressure injuries to patients while using stryker surfaces. No specific incident(s) were reported, and no details were provided regarding any possible medical intervention. Further, no defects were alleged with the units involved in the alleged events.
Patient Sequence No: 1, Text Type: D, B5


[116530027] The customer did not make the units available for inspection and therefore the cause of the alleged injuries cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10


[116530028] It was alleged that the customer was experiencing a general increase in pressure injuries to patients while using stryker surfaces. No specific incident(s) were reported, and no details were provided regarding any possible medical intervention. Further, no defects were alleged with the units involved in the alleged events.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2018-00669
MDR Report Key7691803
Date Received2018-07-16
Date of Report2018-08-07
Date of Event2018-06-18
Date Mfgr Received2018-06-18
Date Added to Maude2018-07-16
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 ContactMR. CHANDA BURGHARD
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693292100
Manufacturer G1STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
Manufacturer Street1020 ADELAIDE ST. S.
Manufacturer CityPORTAGE MI N6E 1R6
Manufacturer CountryCA
Manufacturer Postal CodeN6E 1R6
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameISOFLEX LAL 2860
Generic NameBED, FLOTATION THERAPY, POWERED
Product CodeIOQ
Date Received2018-07-16
Catalog Number2860000000
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
Manufacturer Address1020 ADELAIDE ST. S. PORTAGE MI N6E 1R6 CA N6E 1R6


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-16

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