UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for UNKNOWN manufactured by Unknown.

Event Text Entries

[70789981]
Patient Sequence No: 1, Text Type: N, H10


[70789982] The pt attempted to sit in the recliner but sat on the leg rest, causing pt to fall. No external injuries were noted. The pt denies pain. Their doctor was made aware, we will continue to monitor. Cannot get any manufacture info off of the chair. Patient simply sat on the foot rest instead of into the chair seat and fell/slid off. No injuries occurred. All physicians were notified at time of incident. A post fall huddle was performed at the patient's bedside following the incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6431596
MDR Report Key6431596
Date Received2017-03-24
Date of Report2017-03-08
Date of Event2016-10-31
Report Date2017-03-08
Date Reported to FDA2017-03-08
Date Reported to Mfgr2017-03-08
Date Added to Maude2017-03-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameCHAIR, EXAMINATION AND TREATMENT
Product CodeFRK
Date Received2017-03-24
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-24

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